Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 Recall...Read More

Company: Elekta Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Recall Number: Z-2406-2021 REASON If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis...Read More

Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 9/8/2021 Class II PRODUCT CombiDiagnost R90 Software Version R1.0 and R1.1 Recall Number: Z-2357-2021 REASON Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT Merge Hemo, Software packages 10.2, 10.3, and 10.4 Recall Number: Z-2387-2021 REASON The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on...Read More