—#95402

Product

Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033737, K041949
Affected lot / code info: Site Numbers: 104075, 104497, 537745, and 51333258.

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.

Timeline

Recall initiated: 2010-11-04
Posted by FDA: 2011-03-22
Terminated: 2011-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95402. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.