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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Services

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 Class 2 Device Recall Guardian Servicessee related information
Date Initiated by FirmJuly 31, 2009
Date PostedNovember 10, 2009
Recall Status1 Terminated 3 on January 08, 2010
Recall NumberZ-0168-2010
Recall Event ID 53133
Product Classification Digital Image Storage Radiological Device - Product Code LMB
ProductGuardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
Code Information All accounts that have NetPractice and are signed up for Guardian Services backup.
Recalling Firm/
Manufacturer		 Stryker Imaging
1410 Lakeside Pkwy Ste 600
Flower Mound TX 75028-4027
Manufacturer Reason
for Recall		Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis.
FDA Determined
Cause 2		Other
ActionFirm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.
Quantity in Commerce55 devices affected
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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