Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Reported: July 6, 2022 Initiated: June 10, 2022 #Z-1294-2022
Product Description
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Reason for Recall
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 136 systems
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 136 systems.
Why was this product recalled? ▼
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1294-2022.
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