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
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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
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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 |
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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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