Recall Z-1594-2016 ยท LLZ System, Image Processing, Radiological
Carestream Health Inc
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Lap
| Date | May 2, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". |
| Root cause | Software design |
| Action | Carestream Health sent an URGENT MEDICAL DEVICE CORRECTION letter dated April 6, 2016, and Consignee Notification Acknowledgement form to the US consignees on April 15, 2016, via Certified Mail, Return Receipt Requested. Foreign consignees are being notified based on the individual country regulations. Customers who have this Image Suite configuration but do not use it for CT or MR Imaging do not need to take any action. Customers who use the product for CT or MR Images are asked to make users aware of the problem and take additional steps to check correct orientation of any markers, until t |
| Quantity | US: 37 units, Foreign: 269 units |
| Distribution | NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, Fran |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100094 | CARESTREAM IMAGE SUITE Carestream Heatlh, Inc., Mar 11, 2010 |