Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of the monitor falling and causing serious injury to patients, operators, or bystanders.
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: FDA Class II recall involving a mechanical failure (shaft wear) that could cause serious injury through device detachment and falling. No illnesses or injuries have been reported, meeting the criteria for a risk-of-harm medical device without reported harm.
Plain-English summary
Philips North America is recalling approximately 1,301 Monitor Bracket Assemblies used in medical imaging systems. These components are part of Continuous CT Fluoroscopy DVI Ceiling Mount systems and CCT Arm DVI Option configurations for PET/CT imaging equipment (model 882446).
The Monitor Bracket Assembly shaft can experience significant wear that may not be immediately recognized. When this wear becomes severe enough, the bracket assembly can detach from the suspension arm, allowing the monitor to fall while remaining attached to its electrical cables.
This detachment and fall creates a potential hazard where patients, operators, bystanders, or service personnel could suffer serious injury. The affected devices have been distributed worldwide, including throughout the United States, Canada, Mexico, and numerous other countries.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
- Manufacturer
- Philips North America Llc
- Affected units
- 1,301
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 (1)
- Model/ Serial Number/UDI: N/A 882446 900115 (01)00884838059559(21)900115
Distribution
Part of a larger recall action
This product is one of 12 recalled by Philips North America Llc 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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