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MAGNETOM systems, magnetic resonance diagnostic devices… recallZ-0467-2016 · Siemens Medical Solutions USA, Inc · initiated Dec 7, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0467-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 7, 2015
Posted by the FDA
Dec 22, 2015
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
in US 3752 units
Product code
LNH
FDA submissions
K002179, K032428, K130885, K132951, K133226
Distribution
Nationwide including : DC, PR, Virgin Islands and Bermuda

Product description

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

Code information (models, lots, serial numbers)

all units distributed since 1991

Other devices under the same FDA submission

7 devices cleared under K002179, K032428, K130885, K132951, K133226 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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