Z-1306-04

EasyDiagnost Eleva Part Number 989605071921

Name: Z-1306-04 EasyDiagnost Eleva Part Number 989605071921
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-06-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-06-08 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of EasyDiagnost Eleva Part Number 989605071921 on 2004-06-08. The reason FDA records is "When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1306-04
Status: Terminated
Initiated: 2004-06-08
Posted: 2004-08-04
Terminated: 2006-02-09
Recalling firm: Philips North America LLC
Product: EasyDiagnost Eleva Part Number 989605071921
Product code: KPR System, X-Ray, Stationary
Reason for recall: When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
FDA root cause: Other
Action: The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
Quantity in commerce: 46
Distribution: Philips Medical Systems North American Company distributes product to medical facilities nationwide.
Product codes and lots: The firm uses site numbers instead of serial numbers. 103164, 105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749, 505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015, 504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551, 505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522, 103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798, 105640, 105776, 506199, 504804, 504803.

Product code KPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)