Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (O
FDA device recall Z-0134-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- Stryker Imaging
- Reason for recall
- Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 12 devices affected
- Distribution
- Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.
- Date initiated
- 2009-08-31
- Date posted
- 2009-11-09
- Date terminated
- 2010-04-14
- Location
- Flower Mound, TX
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