The Recall Desk
LowFDA (Devices)·Z-1663-2014·Announced 2014-06-04

Siemens Recalls MAGNETOM Aera Systems Due to Missing Operator Manuals

Siemens is recalling five MAGNETOM Aera magnetic resonance systems because a processing error may have prevented some users from receiving their Operator Manuals.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (missing manuals) rather than a physical defect or safety hazard that poses an immediate risk of injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling five MAGNETOM Aera magnetic resonance systems. The recall is due to a processing error that may have resulted in some users not receiving the Operator Manuals for the devices.

The affected units are model # 10432914 with serial numbers 52126, 52135, 52108, 52025, and 52101. These systems were distributed in the states of Minnesota, California, Colorado, Texas, and Iowa.

The MAGNETOM Aera is indicated for use as a magnetic resonance diagnostic device that produces cross-sectional and spectroscopic images. Users should contact Siemens Medical Solutions USA, Inc. to verify if they have received the required documentation.

The recalled product

Product
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or func
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • model # 10432914 with serial numbers: 52126 52135 52108 52025 52101

Distribution

Distributed in 5 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →