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Terminated

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

FDA Recall Z-1990-2014 · Posted 2014-07-02

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLRG
Date Initiated2014-06-02
Date Terminated2015-12-23
Product QuantityWA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.

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.

Firm Action

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.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911400WALKAWAY TM 40Baxter Healthcare Corp · 1991-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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