NA SIGNA Voyager (REF M70012TB)Recalls & reported problems
Ge Healthcare(Tianjin) Company Limited · Kizuna System Medical Device Assembly · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K161567, K192426); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 20, 2025Open, Classified
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Z-2300-2025 · Root cause: Equipment maintenance · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161567, K192426. One submission often covers many models, so check the product and lot details in each record.
- Z-0599-2022 · Dec 23, 2021 · Open, ClassifiedGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
- Z-0138-2022 · Aug 26, 2021 · TerminatedSIGNA Voyager nuclear magnetic resonance imaging system
- Z-2062-2021 · Jun 4, 2021 · Open, ClassifiedSIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Other System, nuclear magnetic resonance imaging devices
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging14 recalls12 reports
- Ingenia Elition SPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging13 recalls2 reports
- NA Discovery MR750w 3.0TGE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging13 recalls0 reports
- Ingenia Ingenia Ambition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging12 recalls12 reports
- Ingenia Ingenia 3.0T CXPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls59 reports
- Ingenia Smartpath to dStream for 3.0TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls44 reports
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls5 reports
- MR 7000 Series MR 7700Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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