Carestream DRX Revolution Mobile X-Ray System Recalled for Image Artifacts
Carestream Health is recalling 23 DRX Revolution Mobile X-Ray Systems because a software update without detector calibration can cause image artifacts.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves image artifacts that could affect diagnostic accuracy, but no injuries or illnesses are reported in the source text.
Plain-English summary
Carestream Health, Inc. is recalling 23 units of the DRX Revolution Mobile X-Ray System, Model DRXR-1. The affected devices are identified by specific catalog numbers and serial numbers listed in the recall notice. The units were distributed worldwide, including in the United States and several international countries.
During an audit, Carestream discovered that the system could capture images displaying artifacts. This issue occurs when the DRX product console software is updated to version 5.6b and the detector is not calibrated before use. The defect was discovered during manufacturing.
The recall affects 23 installed units, with 11 located domestically in the United States and 12 located internationally. Affected serial numbers include U.S. units 134, 152, 173, 174, 200, 205, 222, 312, 349, 353, and 412, as well as worldwide units 469, 445, 306, 410, 453, 204, 483, 300, 171, and 218. Users should contact Carestream Health for instructions on resolving the calibration issue.
The recalled product
- Product
- DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient
- Manufacturer
- Carestream Health, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: U.S. - 134
- 152
- 173
- 174
- 200
- 205
- 222
- 312
- 349
- 353
- 412
- Worldwide Serial numbers: 469
- 445
- 306
- 410
- 453
- 204
- 483
- 300
- 171
Distribution
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