Philips Diagnost Stationary Radiographic System Recalled for Table Height Non-Compliance
Philips Healthcare Inc. is recalling 101 units of Diagnost Stationary Radiographic Systems because installation records show table height measurements out of specification.
What this means for you
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 a documentation and installation compliance issue (IATD non-compliance) with no reported injuries, illnesses, or immediate physical hazards to patients.
Plain-English summary
Philips Healthcare Inc. is recalling 101 units of the Philips Diagnost Stationary Radiographic System, including models 712020, 712022, 712050, 712052, 712055, 712057, and 712062. The recall involves units distributed nationwide in the United States and in Canada.
The recall was initiated because the Installation Acceptance Test Document (IATD) was found to be non-compliant with regulations. Records indicate that table height measurements were out of specification, which may result in potential system mis-alignment.
Affected users should contact Philips Healthcare Inc. for further instructions regarding the remediation of these units.
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.
- Affected units
- 101
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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