GE Healthcare — Class II medical device recall Z-2291-2013
Terminated recall by GE Healthcare, LLC, reported 2013-10-09, distributed in DC, HI, ND, RI, WY. GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bell
| Recall number | Z-2291-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-04-25 |
| Distributed | DC, HI, ND, RI, WY |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, ID, IL, IN, IT, JP, KR, KW, LB, MX, NL, NO, NZ, OM, PL, QA, RS, RU, SA, SE, SG, TR, TW, UY, ZA |
| Serial numbers | 00000029854MR5, 00000030090MR1, 00000288156MR3, 00000288409MR6, 00000288907MR9, 00000289309MR7, 00000289310MR5, 00000289961MR5, 00000290050MR4, 00000290137MR9, 00000290202MR1, 00000290456MR3, 00000290457MR1, 00000290502MR4, 00000290545MR3, 00000290659MR2, 00000290773MR1, 00000290957MR0, 00000290985MR1, 00000291008MR1, 00000291154MR3, 00000291185MR7, 00000291274MR9, 00000291325MR9, 00000291345MR7 and 475 more |
Product
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.