The Recall Desk
HighFDA (Devices)·Z-0217-2020·Announced 2019-11-13

Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard

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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

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 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 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: 889471 System Serial Number: 1

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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