AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Reported: August 1, 2018 Initiated: May 25, 2018 #Z-2525-2018
Product Description
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Reason for Recall
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 6 units US
- Distribution
- HI , IL, MI, NC, NY, VA, WI
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6 units US.
Why was this product recalled? ▼
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2525-2018.
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