Philips Medical Systems North America Co. Phillips General X-Ray System types with Digital Spot Imaging (DSI) software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
General X-Ray System types with Digital Spot Imaging (DSI) software
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
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
Products Sold
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
Philips Medical Systems North America Co. Phillips is recalling General X-Ray System types with Digital Spot Imaging (DSI) software due to 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 b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026