PlainRecalls
FDA Devices Moderate Class II Terminated

MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

Reported: July 9, 2014 Initiated: June 2, 2014 #Z-1990-2014

Product Description

MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

Reason for Recall

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.

Details

Units Affected
WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
Distribution
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.
Location
West Sacramento, CA

Frequently Asked Questions

What product was recalled?
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1990-2014.