The Recall Desk
HighFDA (Devices)·Z-0214-2020·Announced 2019-11-13

Philips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk

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

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: The recall involves a mechanical defect in a medical device where a component may fall unimpeded, posing a risk of harm. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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 are identified by System Codes 882290 and 882291. 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 source text does not specify instructions for consumers or medical personnel regarding the 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: 882290 and 882291 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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