All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
All Recalls
95,038 total recalls in our database
🏥 Medical Devices Class I - Dangerous
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
🏥 Medical Devices Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
VITROS 250 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Burstberry Laser Projection Series
Gk Photonics
🏥 Medical Devices Class I - Dangerous
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
🏥 Medical Devices Class I - Dangerous
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
🏥 Medical Devices Class I - Dangerous
Failure to comply event due to incorrect labeling of a class 1 laser product.
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
🏥 Medical Devices Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
ROi Consolidated Service Center (CSC)
🏥 Medical Devices Class I - Dangerous
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
🏥 Medical Devices Class I - Dangerous
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
🏥 Medical Devices Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
🏥 Medical Devices Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
VITROS 250AT Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.