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U.S. Department of Health and Human Services

Class 2 Device Recall Omni Diagnost Eleva

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  Class 2 Device Recall Omni Diagnost Eleva see related information
Date Initiated by Firm July 23, 2007
Date Posted September 25, 2007
Recall Status1 Terminated 3 on September 17, 2012
Recall Number Z-0911-2007
Recall Event ID 44910
510(K)Number K032046  
Product Classification X-Ray System - Product Code IZI
Product Philips Omni Diagnost Eleva
Code Information Site numbers 500046, 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
FDA Determined
Cause 2		 Other
Action On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
Quantity in Commerce 14 units
Distribution Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
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.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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