Philips Forte Gamma Camera System Recalled for Detector Fall Hazard
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,167 Forte Gamma Camera Systems. The recall is due to an issue with the detector that may cause either detector 1 or detector 2 to fall unimpeded vertically to the end stops of its travel limit.
The affected systems have System Codes 882320 and 882321. The products were distributed nationwide. The Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
The U.S. Food and Drug Administration has classified this as a Class I recall. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 1,167
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)
- System Code: 882320 and 882321 All systems.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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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