—#91737

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.

Timeline

Recall initiated: 2010-05-05
Posted by FDA: 2010-09-15
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.