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Terminated

General X-Ray System types with Digital Spot Imaging (DSI) software

FDA Recall Z-2160-2008 · Posted 2008-08-25

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZJ
Date Initiated2008-05-23
Date Terminated2010-09-28
Product Quantity41 units

Reason for Recall

X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).

Firm Action

On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920793PHILIPS DSI SYSTEM RELEASE 3.2Philips Medical Systems, Inc. · 1992-07-17

Official Source

View FDA Recall →

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

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