Recall Z-2124-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Esaote S.p.A.
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
| Date | Jul 5, 2016 (initiated Jun 6, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Esaote initiated a voluntary recall of the G-scan Brio Magnetic Resonance System on 06/06/2016 with letters sent via certified, due to a potential weakness on the extremity areas of the patient table that could lead to a stress fracture of the table. The firm has instructed customers to refer to the Medical Device Safety Notification provided with the recall notice, date and sign this letter in the space provided on the last page and send it back via email to quality@esaoteusa.com. If customers have questions regarding the recall, please call 1-317-813-6030. For additional information, pleas |
| Quantity | 11 USA; 29 OUS |
| Distribution | Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142421 | G-scan Brio Esaote, S.p.A., Apr 9, 2015 |