BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.
All Recalls
95,114 total recalls in our database
Ingenia 1.5T, magnetic resonance imaging system.
Philips Medical Systems
🏥 Medical Devices Class I - Dangerous
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
🏥 Medical Devices Class I - Dangerous
Potential for the welded seam in affected monitor spring arms to crack and/or break.
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
🏥 Medical Devices Class I - Dangerous
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Ingenia 1.5T R5, magnetic resonance imaging system.
Philips Medical Systems
🏥 Medical Devices Class I - Dangerous
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
🏥 Medical Devices Class I - Dangerous
Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.
🏥 Medical Devices Class I - Dangerous
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
🏥 Medical Devices Class I - Dangerous
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
🏥 Medical Devices Class I - Dangerous
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.