FDA-Device2014-07-09Class II
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Siemens Healthcare Diagnostics, Inc.
Hazard
Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.
Affected count
WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
Manufactured in
2040 Enterprise Blvd, West Sacramento, CA, United States
Products
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1990-2014Don't want to check this manually?
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