Reported Jan 27, 2016 · Terminated
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or…
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 Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ
- using the following techniquesplanar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV
- Lot codes and dates
- e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.
- Amount recalled
- 10
Where it was sold
Why it was recalled
To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
This product could cause temporary or reversible health problems — stop using it.
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