Philips ADAC Nuclear Gamma Cameras Recalled for Potential Patient Contact
Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.
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 involves a risk-of-harm product (potential physical contact with patient) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,043 nuclear gamma cameras, including the ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60, and ADAC Vertex Classic models. These devices are used to produce images depicting the anatomical distribution of radioisotopes in the human body for interpretation by medical personnel.
The recall is due to a defect where slippage of the radius drive belt in the superior positioned detector head allows the head to drift down. This drift could potentially bring the detector head into direct contact with the patient. The affected units were distributed worldwide, including in the United States and numerous international markets.
Healthcare facilities and users of these devices should check their equipment against the specific serial numbers and system codes listed in the official recall notice. If a device is affected, it should be taken out of service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,043
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)
- ADAC Vertex Plus & ADAC Solus System Code: 88297
- Serial #'s: 11
- 1006
- 1008
- 1027
- 1092
- 1097
- 2035
- 2038
- 2047
- 3059
- 3060
- 3064
- 4007
- 4078
- 6052
- 6261
- 8002
- 10252
- 10630
Distribution
Distribution scope not specified by the agency.
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