Philips ADAC Vertex Gamma Cameras Recalled for Mechanical Drift Hazard
Philips Medical Systems is recalling 918 ADAC Vertex Gamma Cameras because detector heads may drift and contact patients during imaging.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the source describes a specific incident where the device made contact with a patient, representing a risk of harm without reported serious injury or death.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 918 units of Nuclear Gamma Cameras, specifically the ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, and ADAC VERTEX V60 models. The recall was initiated after a mechanical defect was identified during clinical use.
The hazard involves the detector heads drifting downward when positioned at a relative 180-degree angle. In a reported incident, Detector #1 drifted down and made contact with a patient's chin during a whole body study acquisition. This mechanical failure poses a risk of physical injury to patients undergoing imaging.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international countries. Healthcare facilities and consumers should check their equipment serial numbers against the list provided by the manufacturer and contact Philips Medical Systems for instructions on corrective action.
The recalled product
- Product
- Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 918
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 (20)
- Vertex Classic
- Model #: 890122
- Serial #s: 9404100
- 9601238
- 9609084
- 0407V
- 0682V
- 0795V
- 0822VP2
- 103
- 20
- 500
- 5405V
- 64
- 9308007
- 9309020
- 9310032
- 93-10660-1292
- 9401059
- 9401061
Distribution
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