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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS icono (Ceiling Configuration)

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 Class 2 Device Recall ARTIS icono (Ceiling Configuration)see related information
Date Initiated by FirmOctober 17, 2023
Date PostedDecember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0523-2024
Recall Event ID 93338
510(K)NumberK221516 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Code Information UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith Adams
610-219-4834
Manufacturer Reason
for Recall		Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
FDA Determined
Cause 2		Component design/selection
ActionOn October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce38 worldwide, 11 US
DistributionUS Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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