Esaote G-scan Brio MRI System Recalled for Table Fracture Risk
Esaote S.p.A. is recalling G-scan Brio MRI systems because dynamic loading forces from larger patients can fracture the patient table's extremity portion.
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 where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Esaote S.p.A. is recalling the Magnetic Resonance System G-scan Brio (Part Number /Model No. 101002000). The recall involves 11 units in the United States and 29 units outside the United States. Domestic distribution includes Florida, Texas, Ohio, Minnesota, and Nevada.
The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.
Healthcare facilities should contact Esaote S.p.A. for instructions on how to proceed with the recall and the implementation of the weight limit for the patient seat.
The recalled product
- Product
- Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Manufacturer
- Esaote S.p.A.
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 (17)
- Item No.
- Unit Description and Serial No.s: 101002000
- UNIT
- G-SCAN BRIO
- 05202
- 101002000
- 05203
- G-SCAN BRIO 2.1A
- 05205
- 05207
- 101002000 UNIT
- 05208
- 05209
- 05210
- 05211
- 05305
- 05308
Distribution
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