—#128140

Product

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

FDA product code: LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K911400
Affected lot / code info: WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.

Why it was 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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

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.

Timeline

Recall initiated: 2014-06-02
Posted by FDA: 2014-07-02
Terminated: 2015-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.