Recalls / —

—#64650

Product

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

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K033737

Affected lot / code info

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.

Why it was recalled

Inaccurate anatomical measurements when using the optional SmartMask feature

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2007-09-24

Posted by FDA

2007-12-07

Terminated

2012-05-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #64650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.