Z-2423-2010

Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA...

Name: Z-2423-2010 Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-05-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-05-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers... on 2010-05-05. The reason FDA records is "Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2423-2010
Status: Terminated
Initiated: 2010-05-05
Posted: 2010-09-15
Terminated: 2010-10-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an Urgent Field Safety Notice in May 2010 to customers with information on what to do if the battery leaks, overheats, or vents an odor. Firm also issued a Support Bulletin to field service personnel to inspect and replace affected units.
Quantity in commerce: 228 units
Distribution: Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.
Product codes and lots: Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments within the serial number range of B01060900055 through B01090100414R0, excluding B01081100388R0, B01081100389R0, B01081200396R0, B01081200402R0, B01081200403R0, B01081200404R0, B01081200406R0, B01081200408R0, B01081200410R0, B01081200411R0, B01090100412R0, B01090100413R0.

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)