Z-1079-04

Emission Computed Tomography System

Name: Z-1079-04 Emission Computed Tomography System
Creator: Adac Labs
Published: 2004-06-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-06-21 / Terminated / root cause: software

FDA source

Adac Labs began a recall of Emission Computed Tomography System on 2004-06-21. The reason FDA records is "Software problems may cause the detector head to drift unexpectedly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1079-04
Status: Terminated
Initiated: 2004-06-21
Posted: 2004-07-20
Terminated: 2005-12-19
Recalling firm: Philips North America LLC
Product: Emission Computed Tomography System
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Software problems may cause the detector head to drift unexpectedly
Root cause tag: software
FDA root cause: Other
Action: Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)
Quantity in commerce: 482 units
Distribution: Nationwide, all direct accounts
Product codes and lots: model number 2163-3000A, 2163-3000B

Product code KPS

K011611Class IICardiocam Model 9Csy0799Danish Diagnostic Development A/S / cleared 2001-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)