Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reported: July 8, 2020 Initiated: June 10, 2020 #Z-2442-2020
Product Description
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reason for Recall
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Details
- Recalling Firm
- Elekta Instrument AB
- Units Affected
- 51 devices
- Distribution
- MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887. Recalled by Elekta Instrument AB. Units affected: 51 devices.
Why was this product recalled? ▼
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2442-2020.
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