The Recall Desk
SevereFDA (Devices)·Z-0216-2020·Announced 2019-11-13

Philips Forte Gamma Camera System Recalled for Falling Detector Hazard

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 1,167 Forte Gamma Camera Systems. The recall is due to a defect in 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 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.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The recall is classified as Class I by the FDA.

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: 889456 System Serial Number: 24

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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Same manufacturer · Philips Medical Systems (Cleveland) Inc

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