FDA Device Recall Z-0022-2015: Philips Medical Systems, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2015.

Recall Res Number

Z-0022-2015

Recalling Firm / Manufacturer

Philips Medical Systems, Inc.

FEI Number

1218950

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-08

Date Posted

2014-10-09

Date Terminated

2014-12-03

Product Code

OWB

Event Number

69197

Product Quantity

one system

Product Description Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Reason for Recall Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Action Details Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501.

Distribution Pattern US distribution to FL

Code Information / Serial Numbers Model Number: Integris Allura 15-12 Serial Number: 16741023

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Medical Device Recall: Z-0022-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer