Z-0330-2008

Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021

Name: Z-0330-2008 Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-09-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-09-24 / Terminated / root cause: design

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 on 2007-09-24. The reason FDA records is "Inaccurate anatomical measurements when using the optional SmartMask feature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0330-2008
Status: Terminated
Initiated: 2007-09-24
Posted: 2007-12-07
Terminated: 2012-05-03
Recalling firm: Philips North America LLC
Product: Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Inaccurate anatomical measurements when using the optional SmartMask feature
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.
Quantity in commerce: 53 units
Distribution: Nationwide
Product codes and lots: Serial numbers affected: 18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691.

Product code IZI

K033737Class IIAllura Xper Fd20Philips Medical Systems North America, Inc. / cleared 2003-12-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)