FDA Device Recall Z-0031-2007: AGFA Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-2007.

Recall Res Number

Z-0031-2007

Recalling Firm / Manufacturer

AGFA Corp.

FEI Number

3001236302

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-06-28

Date Posted

2006-10-12

Date Terminated

2007-05-10

Product Code

MQB

Event Number

35994

Product Quantity

11 units

Product Description CR DX-S, Image Intensified Fluoroscopic X-ray system.

Reason for Recall Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

Action Details Consignees were notified by letter on/about 06/28/2006.

Distribution Pattern CA, DC, FL, MN, MI, MS, OR.

Code Information / Serial Numbers Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.

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Medical Device Recall: Z-0031-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer