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Terminated

KION Anesthesia System.

FDA Recall Z-0710-05 · Posted 2005-04-14

Recalling FirmMaquet Inc
Recall StatusTerminated
Product CodeBZR
Date Initiated2005-01-11
Date Terminated2005-06-16
Product Quantity40

Reason for Recall

Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

Firm Action

MCC has assigned an internal task team to manage plan and perform the correction ofthe installed base of KION (intended for clinical use) in US. Updates started on January 11, 2005.

Root Cause

Other

Distribution Pattern

The systems were distributed to hospitals throughout the nation.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024213SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655Siemens Medical Solutions USA, Inc. · 2004-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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