Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-
FDA device recall Z-0160-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Stryker Imaging
- Reason for recall
- Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 85
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-08-03
- Date posted
- 2009-11-10
- Date terminated
- 2010-01-26
- Location
- Flower Mound, TX
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