Recall Z-0160-2010
Stryker Imaging · initiated August 3, 2009
Product
Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.
Codes / lots: All accounts that have OrthoPad and are signed up for Guardian Services backup.
Reason for recall
Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.
FDA-determined cause: Other
Action taken
Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.
Details
- Recall number
- Z-0160-2010
- Initiated
- August 3, 2009
- Posted by FDA
- November 10, 2009
- Terminated
- January 26, 2010
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 85
- Distribution
- Nationwide Distribution
- Recalling firm
- Stryker Imaging, Flower Mound, TX