ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
🏥 Medical Devices Class I - Dangerous
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Philips S5-1 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips S7-2 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips 3D9-3v Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips X7-2t Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
This device does not indicate for use in patients with respiratory failure.
Philips X5-1 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Philips S8-3t Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips XL14-3 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips C5-1 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
Cather packaging may contain the incorrect French size.
Philips L12-4 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Servo-n Ventilator System. Model Number: 6694800.
Maquet Critical Care AB
🏥 Medical Devices Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Change Healthcare Cardiology Hemo Software
CHANGE HEALTHCARE CANADA COMPANY
🏥 Medical Devices Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.