Philips Medical System Allura Xper X-Ray Angiographic

FDA device recall Z-1120-2015 · posted 2015-03-02 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

Action taken

Philips Medical Planned Action: 1. The affected customers will be sent a customer notification letter that identifies the software corrective actions and indicates that these corrective actions will be provided to the end-user free of charge 2. A mandatory Field Change Order with reference FCO72200270 will be released that requires Philips field service engineers to install Software release R7.2.8 which addresses the buzzer issue. The expected date of this FCO will be February 2015. The software release will contain updated timer function code to correct the intermittent fluoroscopy timer malfunction. 3. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. 4. The software solutions will be rolled out consecutively, each within a maximum completion time of 6 months. The software releases will be corrected in descending order of the number of affected systems in the field, with approximately 80% of the total installed base corrected by 4 2015.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZI

Quantity affected

7439

Distribution

Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, Chi

Date initiated

2014-06-06

Date posted

2015-03-02

Date terminated

2021-10-15

Location

Andover, MA

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