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Terminated

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.

FDA Recall Z-0134-2010 · Posted 2009-11-09

Recalling FirmStryker Imaging
Recall StatusTerminated
Product CodeLMB
Date Initiated2009-08-31
Date Terminated2010-04-14
Product Quantity12 devices affected

Reason for Recall

Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.

Firm Action

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

Distribution Pattern

Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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