ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #
FDA device recall Z-1311-2023 · posted 2023-03-30 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
- Action taken
- Siemens Healthcare issued A Customer Safety Advisory Notice distributed to customers on 2/2/23 via AX041/22/S. A software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B. Letter states reason for recall, health risk and action to take: Please perform system movements with adequate care to avoid injuries to persons and damage to equipment due to collisions or crushing. Siemens will correct the software error via Update Instructions AX040/22/S. 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 141 units US
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-02-02
- Date posted
- 2023-03-30
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS pheno (K163286) | Siemens Medical Solution USA, Inc. | 2017-03-09 |