medical Class II Updated 2022-04-27

Siemens Medical Solutions USA, Inc recalls Artis Q.zen biplane, Model Number 10848355

Recalled Product

Artis Q.zen biplane, Model Number 10848355

Hazard / Issue

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239

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