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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ARTIS Pheno

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 Class 2 Device Recall Siemens ARTIS Phenosee related information
Date Initiated by FirmJuly 29, 2018
Create DateSeptember 18, 2018
Recall Status1 Terminated 3 on May 17, 2019
Recall NumberZ-3190-2018
Recall Event ID 80905
510(K)NumberK163286 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Code Information 164013 164011
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactAnastasia Sokolova
610-448-6478
Manufacturer Reason
for Recall		Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
FDA Determined
Cause 2		Device Design
ActionUrgent Medical Device Correction notification letters dated 7/27/18 were distributed to customers. The letters informed the customers of the following planned actions: Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX001/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
Quantity in Commerce429 total
DistributionUS nationwide distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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