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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Services

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 Class 2 Recall
Guardian Services
see related information
Date Posted November 09, 2009
Recall Status1 Terminated on April 14, 2010
Recall Number Z-0134-2010
Recall Event ID 53177
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
Product 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.
Code Information All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.
Recalling Firm/
Manufacturer
Stryker Imaging
1410 Lakeside Pkwy Ste 600
Flower Mound, Texas 75028-4027
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 12 devices affected
Distribution Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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