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GE Healthcare (China) Co., Ltd. recalls

The FDA has posted 5 enforcement recalls from GE Healthcare (China) Co., Ltd. since 2025, none of them Class I (most serious). Most recent report: Mar 5, 2025.

Class II: 5
Class IIOngoingZ-1240-2025

GE Healthcare (China) Co., Ltd. recalls Brivo MR355

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display".…

  • Nuclear Magnetic Resonance Imaging System
  • Software design
GE Healthcare (China)…Mar 5, 2025
Class IIOngoingZ-1239-2025

GE Healthcare (China) Co., Ltd. recalls SIGNA Creator

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display".…

  • Nuclear Magnetic Resonance Imaging System
  • Software design
GE Healthcare (China)…Mar 5, 2025
Class IIOngoingZ-1242-2025

GE Healthcare (China) Co., Ltd. recalls SIGNA MR355

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display".…

  • Nuclear Magnetic Resonance Imaging System
  • Software design
GE Healthcare (China)…Mar 5, 2025
Class IIOngoingZ-1243-2025

GE Healthcare (China) Co., Ltd. recalls SIGNA MR380

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display".…

  • Nuclear Magnetic Resonance Imaging System
  • Software design
GE Healthcare (China)…Mar 5, 2025
Class IIOngoingZ-1241-2025

GE Healthcare (China) Co., Ltd. recalls Optima MR360

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display".…

  • Nuclear Magnetic Resonance Imaging System
  • Software design
GE Healthcare (China)…Mar 5, 2025

Firm name as filed with the FDA: “GE Healthcare (China) Co., Ltd.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.