The Recall Desk
SevereFDA (Devices)·Z-0215-2020·Announced 2019-11-13

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.

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 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
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: 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.

See all 5 products in this recall →

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