Class 2 Device Recall Guardian Services

• Date Initiated by Firm: August 31, 2009
• Date Posted: November 09, 2009
• Recall Status: 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 TX 75028-4027
• 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: Other
• 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 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.