Recall Z-0134-2010
Stryker Imaging · initiated August 31, 2009
Product
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.
Codes / lots: All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.
Reason for recall
Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0134-2010
- Initiated
- August 31, 2009
- Posted by FDA
- November 9, 2009
- Terminated
- April 14, 2010
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 12 devices affected
- Distribution
- Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.
- Recalling firm
- Stryker Imaging, Flower Mound, TX