October 2, 2024Medical DevicesFDA
Philips North America recalls IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500
Hazard: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
October 2, 2024Medical DevicesFDA
Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s
Hazard: Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
October 2, 2024Medical DevicesFDA
Becton Dickinson & Co. recalls BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s
Hazard: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
October 2, 2024Medical DevicesFDA
Becton Dickinson & Co. recalls BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of
Hazard: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
October 2, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Hazard: Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Pacemaker, COPM11B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Cysto, FTCY03L; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Nasal Sinus Pack, MTSN26B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls ENT, COEN27N; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Cath Lab Pack, CECL02P; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Vaginal Delivery, ASDV25B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Hand Pack, AKHD97C; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Neuro Vascular, ANKV91A; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls IR Procedure Pack, CEAT19W; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Paracentesis Thoracente, SLPT76H; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Shoulder, SESH18I; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Day Surgery General Pack, FHGE18T; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Open Shoulder, LWOS39L; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Arthroscopy Pack, MSKA45A; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Endovascular AAA Pack, ESED52B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls Endovascular AAA Pack, ESED52B; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls PACEMAKER PACK, SLCV01J; Medical convenience kit
Hazard: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
October 2, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Hazard: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.