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Terminated

Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.

FDA Recall Z-0166-2010 · Posted 2009-11-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2009-07-01
Date Terminated2010-01-12
Product Quantity107 units

Reason for Recall

The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.

Firm Action

The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884912ANGIOSTARSiemens Medical Solutions USA, Inc. · 1989-02-16

Official Source

View FDA Recall →

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

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