FDA Device Recall Z-0022-06: Philips Medical Systems North America Co. Phillips

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-06.

Recall Res Number

Z-0022-06

Recalling Firm / Manufacturer

Philips Medical Systems North America Co. Phillips

FEI Number

1000524572

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-07-27

Date Posted

2005-08-31

Date Terminated

2008-05-20

Product Code

JAK

Event Number

33014

Product Quantity

43 units

Product Description Interis Allura BiPlane X-Ray System

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.

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

Distribution Pattern Devices were distributed to hospitals/medical centers nationwide.

Code Information / Serial Numbers The firm utilizes site numbers: 520582, 531926, 535761, 535775, 520949, 530660, 530654, 522136, 521325, 532241, 531939, 520721, 104949, 530396, 532152, 530653, 532383, 531649, 534756, 533290, 521525, 533397, 534786, 520688, 522456, 520964, 532218, 521149, 520275, 532240, 531758, 520666, 519196, 531799, 519981, 520756, 76992, 534131, 506509, 519197, 533288, 537175, 537181

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Medical Device Recall: Z-0022-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer