Reported Apr 6, 2016 · Terminated
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the…
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. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061
Is this the product you have?
- The E
- CAM gamma camera system Product UsageThe E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
- Lot codes and dates
102758791041300904380213043802210524282605977066059770740598400505989079059890870598909505991109059911170599209907324119073241350732414307324150077608090776093207761161078239200782393807823946078239530782396107823979101515311015153210520745
- Amount recalled
- 3090 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change
This product could cause temporary or reversible health problems — stop using it.
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