MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

FDA device recall Z-0467-2016 · posted 2015-12-22 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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.

Action taken

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 monitor service reports for affected sites. For further questions please call ( 610) 219-6300.

Root cause

Other

Status

Terminated

Product code

LNH

Quantity affected

in US 3752 units

Distribution

Nationwide including : DC, PR, Virgin Islands and Bermuda

Date initiated

2015-12-07

Date posted

2015-12-22

Date terminated

2017-06-21

Location

Malvern, PA

Related 510(k) clearances