Z-1223-03

Easy Access PACS System with software Release 5, 6.2, or 7.2

Name: Z-1223-03 Easy Access PACS System with software Release 5, 6.2, or 7.2
Creator: Philips Medical Systems
Published: 2002-02-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2002-02-13 / Terminated

FDA source

Philips Medical Systems began a recall of Easy Access PACS System with software Release 5, 6.2, or 7.2 on 2002-02-13. The reason FDA records is "Potential display of an incorrect body part description on patient images". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1223-03
Status: Terminated
Initiated: 2002-02-13
Posted: 2003-09-12
Terminated: 2005-04-11
Recalling firm: Philips North America LLC
Product: Easy Access PACS System with software Release 5, 6.2, or 7.2
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential display of an incorrect body part description on patient images.
FDA root cause: Other
Action: On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
Quantity in commerce: 46 units
Distribution: The firm distributed units to 46 hospitals and medical centers located throughout the U.S.
Product codes and lots: To be provided

Product code LLZ

K983447Class IWise (II) Image Management SystemSectra-Imtec AB / cleared 1998-10-29

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)