Z-1369-2011

Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System...

Name: Z-1369-2011 Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2010-11-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-11-04 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of 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... on 2010-11-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1369-2011
Status: Terminated
Initiated: 2010-11-04
Posted: 2011-03-22
Terminated: 2011-07-21
Recalling firm: Philips North America LLC
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.
Product code: IZI System, X-Ray, Angiographic
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 root 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.
Product codes and lots: Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)