Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Recall date
July 29, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3190-2018
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US nationwide distribution.

Why it was recalled

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Get recall alerts

Free email alert whenever Siemens Medical Solutions USA, Inc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Siemens Medical Solutions USA, Inc