Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2367-2012 — Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system

U.S. FDA — Device Enforcement · United States · 2012-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2367-2012
Date of alert
2012-04-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10273100
Reported risk: During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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