All Recalls

95,075 total recalls in our database

Brilliance Big Bore Radiology 728244

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Mar 28, 2018 Other Medical Devices View Details →

CS-7, Model No. A4C1

Konica Minolta Medical Imaging USA

🏥 Medical Devices Class I - Dangerous

Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.

May 9, 2018 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

Apr 16, 2018 Other Medical Devices Nationwide View Details →

When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.

Apr 26, 2018 Other Medical Devices Nationwide View Details →

Invalid calibration with low calibrator S1 while using the product.

Apr 9, 2018 Diagnostic Equipment View Details →

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

Apr 16, 2018 Other Medical Devices Nationwide View Details →

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

May 1, 2018 Other Medical Devices Nationwide View Details →

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

May 1, 2018 Other Medical Devices Nationwide View Details →

Philips Ingenuity Core 728321

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Mar 28, 2018 Other Medical Devices View Details →
🏥 Medical Devices Class I - Dangerous

The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.

May 22, 2018 Other Medical Devices View Details →

Ingenuity Core128 728323

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Mar 28, 2018 Other Medical Devices View Details →

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

May 1, 2018 Other Medical Devices Nationwide View Details →

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

Apr 16, 2018 Other Medical Devices Nationwide View Details →

There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.

May 9, 2018 Infusion Pumps View Details →

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

May 1, 2018 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

Apr 16, 2018 Other Medical Devices Nationwide View Details →