Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Reported: July 13, 2016 Initiated: June 6, 2016 #Z-2124-2016
Product Description
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Reason for Recall
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.
Details
- Recalling Firm
- Esaote S.p.A.
- Units Affected
- 11 USA; 29 OUS
- Distribution
- Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
- Location
- Firenze, N/A
Frequently Asked Questions
What product was recalled? ▼
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000). Recalled by Esaote S.p.A.. Units affected: 11 USA; 29 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2124-2016.
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