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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 Services see related information
Date Initiated by Firm August 03, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on January 26, 2010
Recall Number Z-0160-2010
Recall Event ID 53134
Product Classification Digital Image Storage Radiological Device - Product Code LMB
Product Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)

Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.
Code Information All accounts that have OrthoPad 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		 Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 85
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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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