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New Search Back To Search Results   Medical Device Recalls Class 2 Recall Allura Date Recall Initiated October 12, 2006 Date Posted November 14, 2006 Recall Number Z-0165-2007 Product Allura X-per FD 10/10 x-ray, and fluoroscopy Code Information 127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95, 27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89, 23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified with site numbers: 533397, 531926, 104950, 104953, 103283, 103281, 530653, 104497 Recalling Firm/ Manufacturer Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell , Washington 98021-8431 For Addition Information Contact Sarah Baxter 425-487-7665 Reason For Recall Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue. Action On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers. Quantity in Commerce 47 devices Distribution Nationwide.

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