Recall Z-0467-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
| Date | Dec 22, 2015 (initiated Dec 7, 2015) |
| Status | Terminated |
| Reason | Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others. |
| Root cause | Other |
| Action | Siemens sent an Customer Advisory letter dated December 7, 2015, certified mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter notifies customers of the potential injuries, which may result of improperly installed quench lines. The letter indicates it is the system's owner who is responsible for installing the quench line per the requirements. If Siemens installed the quench lines, the consignee is directed to contact Siemens, who will inspect the quench lines during next maintenance visit. Siemens will |
| Quantity | in US 3752 units |
| Distribution | Nationwide including : DC, PR, Virgin Islands and Bermuda |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002179 | MAGNETOM ALLEGRA SYSTEM Siemens Medical Solutions USA, Inc., Oct 11, 2000 |
| K032428 | MAGNETOM AVANTO MR SYSTEM Siemens Medical Solutions USA, Inc., Oct 16, 2003 |
| K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT Siemens Medical Solutions USA, Inc., May 17, 2013 |
| K132951 | MAGNETOM AERA Siemens Medical Solutions USA, Inc., Nov 15, 2013 |
| K133226 | BIOGRAPH MMR Siemens Medical Solutions USA, Inc., Nov 12, 2013 |