Philips Radiographic Systems Recalled for Non-Compliant Installation Test Documents
Philips Healthcare is recalling 177 stationary radiographic systems because their Installation Acceptance Test Documents were non-compliant with regulations or could not be located.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves documentation issues (missing or non-compliant IATDs) rather than a physical defect or safety hazard that poses a direct risk of harm to patients or operators.
Plain-English summary
Philips Healthcare Inc. is recalling 177 units of the Philips Diagnost Stationary Radiographic System, including models 712020, 712022, 712050, 712052, 712055, 712057, and 712062. These devices are used for universal radiographic applications and were distributed nationwide in the United States and in Canada.
The recall was initiated because the Installation Acceptance Test Documents (IATDs) for these units were found to be non-compliant with regulations. Specifically, the IATDs could not be located, or different templates were used than required. This is a documentation and compliance issue rather than a mechanical defect in the equipment itself.
Affected healthcare facilities should contact Philips Healthcare Inc. to resolve the documentation issues. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 177
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Healthcare Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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