FDA Device

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

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.

What You Should Do

Remedy

Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.

Products

MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Brand
Siemens Healthcare Diagnostics, Inc.
UPC
WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.

Units Affected

WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.