X-ray imaging system ceiling suspension may descend without adequate maintenance
Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall describes a risk-of-harm scenario where failure to perform required maintenance could allow equipment to fall and cause injury. No injuries or illnesses have been reported, making this a potential hazard rather than realized harm, meeting the criterion for High severity.
Plain-English summary
The Philips DigitalDiagnost C50 1.1 is an X-ray imaging system used to generate radiographic images of the human body. The device includes a ceiling-mounted suspension system with a telescopic carriage containing a spring balancer that requires annual preventive maintenance according to the manufacturer's Instructions for Use.
If annual maintenance is not performed as specified, the spring balancer's tension will gradually decay through normal wear and tear. As a result, the ceiling suspension may descend unexpectedly if power to the system is interrupted. This unintended descent could result in injuries to patients being imaged or to healthcare workers.
Approximately 10 units of the affected model were distributed in the US and its territories, with 283 additional units distributed internationally. Facilities with affected devices should ensure that annual preventive maintenance is performed on the telescopic carriage according to the device's Instructions for Use.
The recalled product
- Product
- DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
- Manufacturer
- Philips North America Llc
- Hazard
- falling-equipment
- crush-injury
Distribution
Distributed nationwide across the United States.
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