Recall Z-0134-2010 ยท LMB Device, Digital Image Storage, Radiological
Stryker Imaging
Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan.
| Date | Nov 9, 2009 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis. |
| Root cause | Other |
| Action | Stryker Imaging issued an "Urgent: Device Correction" notice dated August 18, 2009. Customers were notified of the defective product and informed that Stryker will be in contact shortly to coordinate the product correction. Actions to be taken during the interim were also detailed. For further information, contact Stryker Imaging at 1-972-410-7100. |
| Quantity | 12 devices affected |
| Distribution | Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.