The Recall Desk
ModerateFDA (Devices)·Z-0213-2020·Announced 2019-11-13

Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded vertically to the end stops of its travel limit.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard is a mechanical failure (falling detector) with no reported injuries or illnesses in the source text, fitting the criteria for a moderate severity score.

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 result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

The affected systems were distributed nationwide. The product 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 source text does not specify specific actions for consumers or medical personnel to take in response to this recall.

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
Category
Medical Device — Imaging Equipment
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: 882020 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.

See all 5 products in this recall →

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