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Terminated

BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.

FDA Recall Z-2034-2008 · Posted 2008-09-26

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-06-30
Date Terminated2008-12-04
Product Quantity10 units

Reason for Recall

Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)

Firm Action

Medtronic Navigation notified service engineers to retest units for compliance.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

CA, DC, LA, FL. IN, OH, PA, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050996O-ARM IMAGING SYSTEMBreakaway Imaging, LLC · 2005-05-05

Official Source

View FDA Recall →

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

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