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Magnetom Avanto. Magnetic Resonance Imaging System. Model… recallZ-1528-05 · Siemens Medical Solutions USA, Inc · initiated Aug 12, 2005

Terminated All recalls posted in September 2005

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

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDA root cause category: Other

What the company is doing

The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

Recall details

Recall number
Z-1528-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 12, 2005
Posted by the FDA
Sep 9, 2005
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
209 units
Product code
LNN
FDA submissions
K032428
Distribution
The products were shipped to medical facilities and MRI facilities nationwide.

Product description

Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167

Code information (models, lots, serial numbers)

Serial numbers 25007 to 25557

Other devices under the same FDA submission

1 device cleared under K032428 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page