Hitachi Oasis MRI Coil Extension Cable Recalled for Overheating Burn Hazard
Hitachi Medical Systems America Inc is recalling 173 Oasis Coil Extension Cables used with MRI systems because they may overheat and cause burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (burn hazard) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 173 units of the Oasis Coil Extension Cable, an accessory used with the Hitachi Oasis MRI System. The recall was initiated after the firm received a complaint stating that the cable accessory would overheat and pose a burn hazard if touched.
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in Mexico. The specific serial numbers involved in this recall are M001 to M108, M110 to M175, M951, and M952.
Consumers and healthcare facilities should stop using the affected cables immediately and contact Hitachi Medical Systems America Inc for further instructions on the removal action.
The recalled product
- Product
- Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis 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…
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI Accessories
- Hazard
- Affected units
- 173
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 (3)
- Serial #'s: M001to M108
- M110 to M175
- M951 & M952.
Distribution
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 Oasis MRI Systems Recalled for Exposed Belt Hazard
FDA (Devices) · 2018-07-25
Same hazard · burn injury
See all →- SevereVQQQ Gas Patio Heaters Recalled for Fire and Burn Hazards
CPSC · 2026-10-22
- SevereHyundai and Genesis Recall Vehicles Due to Front Seat Fire Risk
NHTSA · 2026-10-08
- SevereSnow Peak Recalls Propane Fireplace Inserts and Lava Rocks
CPSC · 2026-10-08
- SevereDR Power Trimmer Mowers Recalled for Fire and Burn Hazards
CPSC · 2026-10-08
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
Similar recalls
- HighHitachi Oasis MRI Systems Recalled for Exposed Belt Hazard
FDA (Devices) · 2018-07-25
- SevereHitachi Echelon Oval MRI Systems Recalled for Gradient Coil Overheating
FDA (Devices) · 2014-09-10
- HighHitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun
FDA (Devices) · 2017-02-01
- ModerateHitachi Oasis MRI System Recalled for Image Data Transfer Errors
FDA (Devices) · 2017-03-29
- ModerateHitachi Recalls Echelon and Oasis MR Imaging Systems Due to Software Error
FDA (Devices) · 2013-06-26
- HighHitachi Scenaria CT System Recalled for Potential Cable Detachment
FDA (Devices) · 2019-11-13