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U.S. Department of Health and Human Services

Medical Device Recalls

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Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemilu... 2 Jun-30-2016 Beckman Coulter Inc.
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of di... 2 Jun-30-2016 Siemens Medical Solutions USA, Inc
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body. 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body. 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the ... 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology sc... 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scan... 2 Jun-30-2016 Philips Medical Systems (Cleveland) Inc
Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum ... 2 Jun-30-2016 Medical Depot Inc.

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