Reported Feb 22, 2017 · Terminated
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- ONCOR Avant-garde, medical charged-particle
- radiation therapy system Product UsageThe intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
- Lot codes and dates
- Model Number
58634725857920
- and 5857912 Serial Numbers
194 of 194 codes
5377339739865087509370-411970-414470-43434078512051705282550670-4146385555173422370237513695536439043781506070-4316520533833942398140675157534358443953514853915300380270-414370-429670-4235547470-436370-4368379137935833589970-437832415355351535743519528158945374555832253835
- Model Number
- Amount recalled
- 194 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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