Recall Z-2124-2016— Esaote S.p.A.
Class II · Terminated
Class II FDA medical device recall by Esaote S.p.A., initiated 2016-06-06, terminated 2017-05-30. It names one FDA 510(k) clearance: K142421. Product: Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000). Reason: 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..
- Recalling firm
- Esaote S.p.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-06
- Terminated
- 2017-05-30
- Firm location
- Firenze, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.