CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recalled
GE Healthcare is recalling Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System. The recall was initiated on 4 Jun 2021 and the FDA has classified it as Class II.
Recall details
- Recall number
- Z-2063-2021
- FDA event ID
- 88147
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2021
- FDA classified
- 12 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 4 Jun 2021 | Recall initiated by company | |
| 12 Jul 2021 | Classified by FDA | +38 days |
| 21 Jul 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Where it was distributed
Worldwide distributions.
Questions about this recall
Why was it recalled?
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Where was it sold?
Worldwide distributions.
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.
Other products in this recall event
13 other products · FDA event 88147This product is part of a recall event; the main page for the event is Signa Premier recalled by GE Healthcare.
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| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
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