ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Reported: September 26, 2018 Initiated: July 29, 2018 #Z-3190-2018
Product Description
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Reason for Recall
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).
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 429 total
- Distribution
- US nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 429 total.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3190-2018.
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