Z-2160-2008

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

Name: Z-2160-2008 General X-Ray System types with Digital Spot Imaging (DSI) software
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-05-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-05-23 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of General X-Ray System types with Digital Spot Imaging (DSI) software on 2008-05-23. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2160-2008
Status: Terminated
Initiated: 2008-05-23
Posted: 2008-08-25
Terminated: 2010-09-28
Recalling firm: Philips North America LLC
Product: General X-Ray System types with Digital Spot Imaging (DSI) software
Product code: IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
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).
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 41 units
Distribution: Nationwide Distribution.
Product codes and lots: Software version: rel 6 serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164

Product code IZJ

K920793Class IIPhilips Dsi System Release 3.2Philips Medical Systems, Inc. / cleared 1992-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)