Philips MultiDiagnost Eleva X-ray system cable hose carrier detachment
Philips is recalling 109 MultiDiagnost Eleva X-ray systems worldwide due to potential cable hose carrier detachment from broken plastic or bolts, which could cause parts to fall and result in injury.
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 is an FDA Class II medical device recall for a risk-of-harm product where cable hose carrier detachment could occur, but no injuries have been reported. The mechanical failure mechanism (broken plastic/bolts) is identified and credible, but the hazard remains theoretical.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 109 units of the MultiDiagnost Eleva X-ray system (models 708038, 708037, 708036, 708034, and 708032, with or without Flat Detector). All serial numbers of these models are included in this recall. The systems have been distributed in the United States, Canada, and numerous countries worldwide.
The cable hose carrier on these systems may detach due to broken plastic and/or bolts. Detachment of the carrier may result in parts falling and/or portions of the cable hose dropping, which could result in injury.
Users of the affected MultiDiagnost Eleva systems should contact Philips Medical Systems Nederland B.V. for instructions regarding the cable hose carrier issue. Any adverse events related to this device should be reported to Philips and the FDA.
The recalled product
- Product
- System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- cable-hose-detachment
- falling-parts
Distribution
Distributed nationwide across the United States.
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