CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Signa Premier magnetic resonance scanner recalled by GE Healthcare

GE Healthcare is recalling Signa Premier magnetic resonance scanner, distributed nationwide in the US. The recall was initiated on 24 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSIGNA Premier GTINs: 00840682135269 and 00195278010797

Quantity recalled52

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1430-2022
FDA event ID: 90587
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2022
FDA classified: 21 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jun 2022	Recall initiated by company
21 Jul 2022	Classified by FDA	+27 days
27 Jul 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

Product as listed by the FDA

SIGNA Premier magnetic resonance scanner, model 5748519.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.

Nationwide Alabama Arizona California Michigan Minnesota New York Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

SIGNA Premier GTINs: 00840682135269 and 00195278010797

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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