FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: General X-Ray System types with Digital Spot Imaging (DSI) software
- Recall number
- Z-2160-2008
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- General X-Ray System types with Digital Spot Imaging (DSI) software
- Status
- Terminated
- Initiated
- 2008-05-23
- Posted
- 2008-08-25
- Terminated
- 2010-09-28
- Reason
- 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
- 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
- 41 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K920793"]
- PMA numbers
- not on file
- Product code
- IZJ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28