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 Recall Z-2423-2010 · Posted 2010-09-15
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2010-05-05
Date Terminated2010-10-25
Product Quantity228 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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