Recall Z-0160-2010 ยท LMB Device, Digital Image Storage, Radiological
Stryker Imaging
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.
| Date | Nov 10, 2009 (initiated Aug 3, 2009) |
| Status | Terminated |
| Reason | Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis. |
| Root cause | Other |
| Action | 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. |
| Quantity | 85 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.