Philips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
Philips Healthcare is recalling 89 Easy Upgrade DR systems because a mirror icon on images could be misinterpreted as a right lead marker if the image is mirrored in a PACS system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the hazard is a potential misinterpretation of an image marker with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Healthcare Inc. is recalling 89 units of the Philips Easy Upgrade DR system (Code No: 712086). This system is used for making X-Ray exposures for diagnostics. The recall was initiated because the mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
The affected units were distributed worldwide, including in the United States (AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA, and TX) and in Canada, Australia, China, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom. Specific serial numbers are listed in the agency's recall record.
No injuries or illnesses have been reported in connection with this recall. Users should contact Philips Healthcare for instructions on how to address the potential misinterpretation of the image marker.
The recalled product
- Product
- Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 89
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)
- 437765/SN09000009
- 452854/SN10000003
- 463879/SN10000016
- 500643/SN12000006
- 504710/SN12000011
- 511454/SN12000018
- 519869/SN13000005
- 524432/SN13000007
- 436570/SN09000008
- 511492/SN12000019
- SN09020039
- SN09010077
- 438946/SN09000011
- SN10002064
- SN11020126
- SN12020282
- 516048/SN12000021
- SN13020163
- 524411/SN13000011
- 409205/SN08000002
Distribution
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