Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
- 2018-10-31FDA-DeviceAmeditech IncClass IIIAccutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.
Product was released to market without the adulteration strip included in the product.
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class II(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 2018-10-31FDA-DeviceCustom Healthcare Systems, Inc.Class IICHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
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