Recall Z-0168-2010 ยท LMB Device, Digital Image Storage, Radiological
Stryker Imaging
Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
| Date | Nov 10, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis. |
| Root cause | Other |
| Action | Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100. |
| Quantity | 55 devices affected |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.