Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Force...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home...
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
I.T.S. Screw System with the below descriptions and corresponding article number...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 2040...
Probes may rupture/burst during activation
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-us...
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the ...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated;...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Ca...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
HLS - Hand Locking Plates System with the below descriptions and corresponding a...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distal Humeral Plates with Angular Stability with the below descriptions and cor...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels...
Due to the likely presence of contamination in well(s).
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System ...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Volar Radius Plate with Angular Stability with the following description: Radius...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ...
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).