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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Allura XPER FD20

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  Class 2 Device Recall Philips Healthcare Allura XPER FD20 see related information
Date Initiated by Firm November 04, 2010
Date Posted March 22, 2011
Recall Status1 Terminated 3 on July 21, 2011
Recall Number Z-1369-2011
Recall Event ID 57106
Product Classification Angiographic X-Ray System - Product Code IZI
Product Allura XPER FD 20 and and Allura CV20;

Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20.

Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Code Information Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.  
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9377 Ext. 5
Manufacturer Reason
for Recall		 Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended.
FDA Determined
Cause 2		 Pending
Action On 11/5/10, Philips began sending the Electronic Product Radiation Warning notification letter, dated November 4, 2010, to their consignees. The consignees were informed that the middle pedal of the foot switch of the Allura FD10, FD20, CV20 systems, and the Allura Field Extension series does not not always become inactive (sticks) when pedal is released. The function of the middle pedal on the foot switch is freely programmable by the customer. If it is programmed for exposure and if the pedal does not release by itself, the patient will be exposed to X-ray longer than intended. The consignees were advised to check if their footswitch is possibly affected. Footswitch identification 452270000141 is noted. If the pedal does not release by itself press the red emergency stop button on the system. Consignees can call Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 72200189.
Quantity in Commerce 7 units in US
Distribution Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
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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