Z-0695-05

Easy Access Image Management System with CL.Net

Name: Z-0695-05 Easy Access Image Management System with CL.Net
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2005-02-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-02-16 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of Easy Access Image Management System with CL.Net on 2005-02-16. The reason FDA records is "Failure to update correctly when re-transmitting an image from the modality". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0695-05
Status: Terminated
Initiated: 2005-02-16
Posted: 2005-04-08
Terminated: 2006-02-13
Recalling firm: Philips North America LLC
Product: Easy Access Image Management System with CL.Net.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Failure to update correctly when re-transmitting an image from the modality.
FDA root cause: Other
Action: The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.
Quantity in commerce: 60
Distribution: Devices distributed to hospitals and medical centers located throughout the U.S.
Product codes and lots: Part Numbers: SW R9.2 for Easy Access Enterprise Edition (W2K); R9.2, R8.2 for Easy Access Enterprise (HPUX 11); Easy Access entry R8.2 and R9.2; R2.1 and R3.1 for EasyAccess Modality The firm utilizes site numbers instead of serial numbers. Site numbers include: 530649, 505274, 506461, 505267, 87076, 101168, 101378, 101590, 102520, 103216, 103220, 103224, 103513, 103767, 104599, 104653, 104679, 104751, 104849, 105106, 105374, 105419, 105517, 105592, 105765, 105826, 105931, 250195, 504436, 504984, 505001, 505025, 505065, 505070, 505183, 505390, 505427, 505506, 505609, 505674, 505778, 505829, 505897, 505973, 506046, 506259, 506330, 506367, 506413, 506453, 506454, 506472, 506699, 519629, 519703, 519977, 520441, 521847, 522273, 526142, 526150, 526153, 526186, 530629

Product code LMB

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)