January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Hazard: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
January 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Hazard: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
January 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Hazard: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
January 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Hazard: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FORCE BIPOLAR,IS4000 REF 471405
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,COBRA GRASPER,IS4000 REF 471190
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,PROGRASP FORCEPS,IS4000 REF 471093
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CADIERE FORCEPS,IS4000 REF 471049
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LONG TIP FORCEPS,IS4000 REF 471048
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FORCE BIPOLAR,IS4000 REF 470405
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.