Medical device recalls

Philips is clarifying labeling on certain Mini Multi TEE Ultrasound Transducers to better define when these devices should no longer be used in clinical settings. The affected units may lack clear guidance on their useful lifespan, which could affect safe operation.

Philips is clarifying labeling on certain L17-5 Ultrasound Transducers to better define their useful life in clinical use. This affects 2 units with specific model and serial numbers distributed nationwide. No injuries have been reported.

Philips is clarifying and updating labeling on certain L12-5 ultrasound transducers to better define their useful life in the field. This affects 40 units distributed nationwide. No injuries have been reported.

Philips Ultrasound, Inc. is clarifying labeling on the C9-4 ultrasound transducer to better define how long the device remains safe and effective in clinical use. This affects a very limited number of units distributed nationwide.

Philips is clarifying and updating labeling on certain 3D6-2 Ultrasound Transducers to better define their useful life in the field. This affects a limited number of units distributed nationwide. No injuries have been reported.

Philips Respironics has recalled Trilogy Evo Universal ventilators (software version 1.05.15.00) because using certain non-pneumatic nebulizers with these machines may cause a mismatch between the breathing volume set by your doctor and the volume your lungs actually receive. This could affect the effectiveness of your ventilation therapy.

Philips Respironics has recalled Trilogy EV300 ventilators (software version 1.05.15.00) because using them with certain types of nebulizers can cause the device to deliver a different amount of air to the patient than what was set. This mismatch between the intended and actual breath volume could affect patient safety.

Philips Respironics has recalled certain Trilogy Evo O2 home ventilators because using non-pneumatic nebulizers with them may cause a mismatch between the breath volume set on the machine and the volume actually delivered to the patient. This discrepancy could result in the patient receiving too much or too little air during ventilation.

Philips Respironics has identified an issue with Trilogy Evo ventilators when used with certain non-pneumatic nebulizers. The ventilator may deliver a different amount of air to the patient than the setting shows, which could affect treatment effectiveness. Philips is working with health care providers and regulators on a solution.

Olympus has identified that two adapter models (MAJ-1443 and MAJ-1444) are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. This means these adapters cannot be safely used with these reprocessing machines. No injuries have been reported.

Olympus has identified that certain adapter models (MAJ-1443 and MAJ-1444) are no longer compatible with the OER-Elite and OER-Pro automated endoscope reprocessors. This incompatibility could affect proper cleaning and sterilization of medical equipment.

Olympus endoscope air/water valves (models MAJ-1443 and MAJ-1444) are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. Using these valves with these reprocessors may result in incomplete or improper cleaning of endoscopes.

Olympus endoscope suction valves (models MAJ-1443 and MAJ-1444) are no longer compatible with Olympus OER-Pro and OER-Elite automated cleaning systems. Using these valves with these reprocessors may result in improper cleaning and sterilization of medical equipment.

Beckman Coulter has recalled MicroScan Neg MIC 56 antimicrobial susceptibility testing panels (Catalog C42464, Lot 2026-01-03) due to potential contamination in the test wells. These panels are used by laboratories to identify bacteria and test antibiotic resistance. Contaminated panels could produce inaccurate test results.

I.T.S. GmbH has recalled certain plates and screws used in pelvic reconstruction surgery because new testing shows they may heat up more than expected during MRI scans under certain conditions. This was not fully described in the original instructions. No injuries have been reported.

I.T.S. GmbH has recalled certain cortical screws, locking stabilization screws, and HLS plates used in hand surgery. New MRI safety testing found these implants may heat up more than expected during MRI scans under certain conditions. The original instructions did not reflect this updated safety information.

I.T.S. GmbH headless compression screws used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated. This affects specific lot numbers of these implants distributed across the United States.

I.T.S. GmbH has recalled certain foot locking plates and hallux osteotomy locking plates used in orthopedic surgery. New MRI safety testing found that these implants may heat up more than expected during MRI scans under certain conditions, which was not fully described in the original instructions.

I.T.S. GmbH is recalling specific DUL and UOL bone plate and screw systems used to stabilize ulna fractures. New MRI safety testing found these implants generate more heat during MRI scans than the original instructions stated, which could potentially cause tissue damage.

I.T.S. GmbH recalled certain distal femur and tibia locking plates used in orthopedic surgery after updated MRI safety testing found they produce higher temperature increases during MRI scans than the original instructions stated. This could potentially cause tissue heating at the implant site during an MRI procedure.

I.T.S. GmbH distal humeral plates and locking cortical screws used in arm surgery may heat more than expected during MRI scans under certain conditions. New testing found the heating levels are higher than what the original instructions stated.

I.T.S. GmbH fibula plates used in orthopedic surgery have been recalled because new MRI safety testing found they heat up more than the instructions originally stated when exposed to certain MRI machine conditions. This could potentially cause tissue burns during an MRI scan.

I.T.S. GmbH has recalled certain Pelvic Reconstruction System components (Fixation Screws and Spike short devices) because updated MRI safety testing found they may heat up more than expected during MRI scans under certain conditions. The original instructions did not fully reflect these temperature increases.

I.T.S. GmbH surgical screws (cannulated cancellous screws, cortical screws, and washers) used in orthopedic surgery can heat up more than expected during MRI scans under certain conditions. New safety testing found the temperature increases are higher than what was stated in the device instructions.

I.T.S. GmbH orthopedic plates used in bone surgery were tested for safety during MRI scans. Testing found these plates can get hotter than originally stated when exposed to certain MRI conditions. The manufacturer has updated safety information to reflect the actual heating levels.

I.T.S. GmbH olecranon plates and olecranon hook plates used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated.

I.T.S. GmbH has recalled certain Pilonplate devices used in orthopedic surgery because new MRI safety testing found they heat up more than expected during MRI scans under certain conditions. The devices affected include Anterolateral Tibia Plates, Pilon Plates 4mm, and Pilon Plates Small with specific article and lot numbers.

I.T.S. GmbH's FR.O.H. Calcaneus Repair System (anterolateral calcaneus plate, Article Number 21064-60) may heat more than expected during MRI scans under certain conditions. New testing found higher radiofrequency-induced temperature increases than the original instructions stated. Only 4 units were distributed nationwide.

I.T.S. GmbH issued a recall for certain Humeral Head Plate with Angular Stability implants used in shoulder surgery. Testing found the device may heat up more than expected during MRI scans under certain conditions. The product labeling did not reflect these updated safety findings.

I.T.S. GmbH clavicle plates used in shoulder surgery may heat up more than expected during MRI scans under certain conditions. New testing found higher temperature increases than the original instructions stated. This affects specific article numbers and lot numbers distributed across the US.