Summary
The FDA issued a Class II for Artis zeego, Model Number 10280959 by Siemens Medical Solutions USA, Inc. Reason: 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 sufficien.
Details
Source
Device Recall
External ID
Z-0973-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Artis zeego, Model Number 10280959
Lot/Code Info: UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488 160997 160864 160448 160937 160965 160427 160455 160884 160486 161236 160435 160451 160823 160951 160384 160431 160100 160916 160814 160872 160391 160470 160321 160376 160915 160447 161021 160481 160401 160119 160403 160404 160871 160989 161051 160874 161223 161007 160862 160438 160860 160378 160419 160889 160450 160854 160429 160149 160878 160137 160152 160153 160154 160138 160446 160368 160957 160992 160394 160856 160432 160147 160433 160483 160402 161005 161209 160813 160998 160356 160425 160148 160337 160460 160485 160443 160370 160912 160381 160412 161215 160919 161217 160407 160876 160861 160325 160885 160910 161000 160494 160390 161050 160507 160144 160833 160001 160363 160825 160341 160139 160942 160816 160430 160873 161233 161234 160840 160006 160462 160505 160956 160445 160322 160323 160382 160421 160474 160428 160116 161016 161017 160131 160318 160369 160498 160413 160414 160128 160373 161004 160978 160551 160327 160865 160830 161224 161235 160338 160141 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 160903 126206 160905 160930 160967 160925 160469
Quantity Affected: 183 systems
Reason for Recall
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".
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-23
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0973-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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