Agency classClass IOur severity:Severe FDA (Devices)·Z-0369-2019·Announced 2018-11-21

GE Healthcare MyoSIGHT Nuclear Cardiology Imaging System Recall for Detaching Detector

GE Healthcare is recalling 276 Millennium MyoSIGHT Nuclear Cardiology Imaging Systems because a detector can detach and fall.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A detector can detach and fall."

Plain-English summary

GE Healthcare, LLC is recalling 276 units of the Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System. The recall was initiated because a detector on the system can detach and fall.

The affected systems were distributed to facilities in the United States, including all 50 states, the District of Columbia, Guam, and Puerto Rico, as well as to numerous international locations. The source text does not specify the exact number of units in each location or the specific dates of distribution.

No illnesses or injuries have been reported in the source text. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging System
Hazard: falling-object
Affected units: 276

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 (20)

System ID #: 0002910670AX
0890013983
0890079382
201461MYO
201858MYO
202464MYO
202741MYO
203483MILL
203688MYO
203797NM13
205739MC
207641MYO
209524MS
209944MS
212420MS
212420MS1
212535MS
212777MS
212870MS
215624MYO

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC 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 3 products in this recall →

Same manufacturer · GE Healthcare, LLC

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