Recall Z-2240-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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
| Date | Jul 27, 2023 (initiated Jun 5, 2023) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | 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 i |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210309 | Cios Select (VA21) Flat Panel Siemens Medical Solutions USA, Inc., Mar 5, 2021 |