Z-1990-2014Class II

MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens...

Name: Z-1990-2014 MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-06-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-06-02 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic on 2014-06-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1990-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Posted: 2014-07-02
Terminated: 2015-12-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Product code: LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 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.
Product codes and lots: WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1990-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1990-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code LRG

K911400Class IIWalkaway Tm 40Baxter Healthcare Corp / cleared 1991-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)