Severity
Moderate
FDA Devices recall · Reported October 27, 2021
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Ge Healthcare, LLC recalled Discovery MR750 3.0T nuclear magnetic resonance imaging system - a moderate-severity action.
Discovery MR750 3.0T nuclear magnetic resonance imaging system was recalled by Ge Healthcare, LLC in October 27, 2021. Reason: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume imag…. Check the official notice for the remedy. Verify recall #Z-0136-2022 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume imag….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0136-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0136-2022) was formally reported on October 27, 2021, with the manufacturer initiating the action on August 26, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 5 devices.
The documented reason for this recall is: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. Distribution data in the federal record shows the product reached: Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
5 devices
Related Recalls
6
3 from same agency
Discovery MR750 3.0T nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0136-2022 |
| Date reported | October 27, 2021 |
| Date initiated | August 26, 2021 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 5 devices |
| Distribution | Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Sau… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 27, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.