Day

March 6, 2013
Company:Intel-GE Care Innovations LLC. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Recall Number Z-0877-2013 REASON Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect...
Read More
Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. RECALLING FIRM/MANUFACTURER Philips...
Read More
Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that...
Read More
Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. Recall Number Z-0881-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to...
Read More
Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number...
Read More
Company:Philips Healthcare Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Recall Number Z-0884-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset...
Read More
Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. Recall Number Z-0880-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray...
Read More
Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Recall Number Z-0703-2013 and Z-0704-2013 REASON It was discovered GE Healthcare...
Read More
Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Recall Number Z-0761-2013 REASON GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code...
Read More

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.