| Date Initiated by Firm |
August 10, 2022 |
| Date Posted |
August 26, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1646-2022 |
| Recall Event ID |
90771 |
| 510(K)Number |
K220409
|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product |
Artis pheno- Model No. 10849000 |
| Code Information |
UDI-DI: 04056869046877
Serial Numbers
164766
164140
164138
164287
164740
164210
164183
164184
164776
164312
164071
164034
164391
164763
164306
164735
164277
164095
164072
164771
164743
164048
164741
164241
164186
164069
164213
164728
164263
164060
164113
164398
164366
164279
164774
164074
164084
164086
164098
164153
164330
164389
164394
164772
164718
164163
164297
164778
164333
164377
164397
164300
164105
164227
164022
164250
164739
164703
164187
164211
164100
164097
164775
164303
164352
164726
164724
164760
164371
***Updated 9/23/22***
164794
164400
***Updated 1/9/23***
164793
164172
164795
|
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact |
Meredith Adams
610-219-4834
|
Manufacturer Reason
for Recall |
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
On August 10, 2022, the firm notified customers via "URGENT: MEDICAL DEVICE CORRECTION" Letter. Customers were advised that if the error occurs, the user should try to recover normal operation by a shutdown and restart of the system.
Siemens will correct the error with a hardware modification via Update Instruction AX028/22/S and AX039/22/S. Siemens' service organization will contact customers shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
If you have any further questions, call 610-219-4834 or email: meredith.adams@siemens-healthineers.com.
|
| Quantity in Commerce |
1,389 (590 US; 799 OUS) (Total) |
| Distribution |
Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan;
Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.
|
| Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions USA, Inc.
|
