Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard
Hitachi Medical Systems America Inc is recalling 264 Oasis MRI systems because an exposed stainless steel belt can cause finger cuts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury (finger cuts) has been reported, but the injuries are not described as serious or life-threatening, fitting the 'High' severity criteria for reported minor injuries without hospitalization.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 264 units of the Hitachi Oasis MRI system. The recall is due to a safety hazard involving the stainless steel belt that runs the length of the table underneath the tabletop. When the tabletop is extended into the magnet for scanning, this belt is exposed.
The firm has received two complaints from technologists who cut their fingers on the exposed belt. The affected units were distributed worldwide and nationwide in the United States, including in the state of Mexico. The specific serial numbers affected are M001 to M028, M030 to M108, M110 to M266, M951, and M952.
Healthcare facilities should contact Hitachi Medical Systems America Inc for instructions on how to address the exposed belt hazard. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, corona
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- M001 to M028
- M030 to M108
- M110 to M266
- M951
- M952
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Hitachi Medical Systems America Inc
See all →- SevereHitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
FDA (Devices) · 2021-03-31
- HighHitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring
FDA (Devices) · 2020-02-26
- HighHitachi Scenaria CT System Recalled for Potential Cable Detachment
FDA (Devices) · 2019-11-13
- HighHitachi Scenaria CT System Recalled for Table Motion Hazard
FDA (Devices) · 2018-08-29
- HighHitachi Ultrasound Transducer Recalled for Electrical Shock Hazard
FDA (Devices) · 2018-03-07
Same hazard · cut injury
See all →- HighHALO Tumblers with Metal Straws Recalled for Laceration Hazard
CPSC · 2024-10-31
- HighPrimal Kitchen Avocado Oil Recalled for Glass Bottle Breakage Risk
FDA (Food) · 2024-07-24
- HighMultichem IA Plus and Controls Recalled Due to Broken Glass Vials
FDA (Devices) · 2023-10-18
- ModerateWinnebago Travel Trailers Recalled for Sharp Cabinet Door Handles
NHTSA · 2022-11-29
- HighMountain Trail Mix recalled due to glass contamination
FDA (Food) · 2021-10-27