| Class 2 Device Recall Cios Select | |
Date Initiated by Firm | June 05, 2023 |
Date Posted | July 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2240-2023 |
Recall Event ID |
92622 |
510(K)Number | K210309 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.
Material #11515088 |
Code Information |
UDI-DI :04056869148243
US S/N:
30001
30002
30008
30013
30029
30031
30032
30033
30034
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Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact | SAME 610-219-4834 |
Manufacturer Reason for Recall | Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts). |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Siemens issued Customer Safety Advisory Notice via AX015/23/S on 6/6/23. Letter states reason for recall, health risk and action to take:
Siemens will correct the hardware error via Update Instruction AX012/23/S. This measure will replace the current single tank cover of all affected systems. Our service organization will contact you 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.
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein |
Quantity in Commerce | 9 units |
Distribution | Worldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY and the countries of Austria, Bangladesh, Brazil, Canada, China, Croatia, El Salvador, France,
Germany, Indonesia, Italy, Japan, Jordan, Lebanon, Luxembourg, Mauritius, Mexico,
Monaco, Peru, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Switzerland,
Taiwan, Ukraine, United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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