Class 2 Device Recall Philips Healthcare Allura XPER FD20

• Date Initiated by Firm: November 04, 2010
• Date Posted: March 22, 2011
• Recall Status: Terminated 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: 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.