FDA-Device2018-10-24Class II
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT
Siemens Medical Solutions USA, Inc.
Hazard
The terminals on the plug may become loose and overheat.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Republic Korea, Lebanon, Sri Lanka, Macedonia, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, Switzerland, Thailand, Turkey, Taiwan, UAE, United Kingdom and Vietnam.
Affected count
890 units
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10529159 p) mCT Flow 20-3R, Material Number 10528956 q) mCT Flow Edge-3R, Material Number 10528954 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief