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Terminated

Emission Computed Tomography System

FDA Recall Z-1079-04 · Posted 2004-07-20

Recalling FirmAdac Labs
Recall StatusTerminated
Product CodeKPS
Date Initiated2004-06-21
Date Terminated2005-12-19
Product Quantity482 units

Reason for Recall

Software problems may cause the detector head to drift unexpectedly

Firm Action

Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)

Root Cause

Other

Distribution Pattern

Nationwide, all direct accounts

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011611CARDIOCAM MODEL 9CSY0799Danish Diagnostic Development A/S · 2001-06-08

Official Source

View FDA Recall →

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

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