Recall Z-0467-2016— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-12-07, terminated 2017-06-21. It names 5 FDA 510(k) clearances: K132951, K133226, K130885 and 2 more. Product: MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-07
- Terminated
- 2017-06-21
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K132951 — MAGNETOM AERA
- K133226 — BIOGRAPH MMR
- K130885 — MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
- K032428 — MAGNETOM AVANTO MR SYSTEM
- K002179 — MAGNETOM ALLEGRA SYSTEM
K-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
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.