Consumer Product Recalls

Hazard: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

Hazard: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

Hazard: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Hazard: Impactor handle may be missing cross-pin

Hazard: Impactor handle may be missing cross-pin

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: The device does not bear a unique device identifier.

Hazard: Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.

Hazard: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.