Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Reported: June 15, 2022 Initiated: April 11, 2022 #Z-1245-2022
Product Description
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Reason for Recall
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 51 units
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 51 units.
Why was this product recalled? ▼
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1245-2022.
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