PlainRecalls
FDA Devices Moderate Class II Ongoing

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Reported: April 5, 2023 Initiated: February 2, 2023 #Z-1311-2023

Product Description

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

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.

Details

Units Affected
141 units US
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 141 units US.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1311-2023.