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Terminated

Interis Allura BiPlane X-Ray System

FDA Recall Z-0022-06 · Posted 2005-08-31

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAK
Date Initiated2005-07-27
Date Terminated2008-05-20
Product Quantity43 units

Reason for Recall

1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.

Firm Action

A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals/medical centers nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002016PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc. · 2000-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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