Agency classClass IOur severity:Severe FDA (Devices)·Z-0371-2019·Announced 2018-11-21

GE Healthcare Millennium MC Medical Device Recall for Detachment Risk

GE Healthcare is recalling 18 Millennium MC units 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 18 units of the GE Healthcare Millennium MC medical device. The recall is due to a safety hazard where a detector can detach and fall.

The affected devices were distributed to various locations in the United States, including Alaska, Alabama, and California, as well as numerous international locations such as Canada, Germany, and Japan. Specific System ID numbers for the affected units are listed in the official recall documentation.

Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this issue. The source text does not provide specific dates or additional details on the distribution scope beyond the listed regions.

The recalled product

Product: GE Healthcare Millennium MC
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: falling-object
Affected units: 18

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 (18)

System ID #: 870735MG
928333WMM02
970635MYO
203576DNT
407896FMG2
954634MG
316267KCN
601883NMC2
910483XEL1
910296MMG
908277XL2
908277MG2
908218MYO
918496EN1
972759CROWNMG
940566MG
972434MC
and 972473MYO.

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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