FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
- Recall number
- Z-0467-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
- Status
- Terminated
- Initiated
- 2015-12-07
- Posted
- 2015-12-22
- Terminated
- 2017-06-21
- 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 monitor service reports for affected sites. For further questions please call ( 610) 219-6300.
- Quantity
- in US 3752 units
- Distribution
- Nationwide including : DC, PR, Virgin Islands and Bermuda
- Lot, serial or model codes
- all units distributed since 1991
- 510(k) numbers
- ["K002179","K032428","K130885","K132951","K133226"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28