FDA Device Recall Z-0041-2007: GE OEC Medical Systems, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2007.

Recall Res Number

Z-0041-2007

Recalling Firm / Manufacturer

GE OEC Medical Systems, Inc

FEI Number

1720753

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-09-13

Date Posted

2006-10-25

Date Terminated

2009-08-13

Product Code

JAA

Event Number

36400

Product Quantity

40 units

Product Description GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.

Reason for Recall Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.

Action Details Consignees will be notified by letter beginning 10/16/2006.

Distribution Pattern FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.

Code Information / Serial Numbers Catalog Numbers 887208 and 887210. Serial numbers E9-0002-G, E9-0004-G, E9-0014-G, E9-0032-G, E9-0035-G, E9-0036-G, E9-0040-G, E9-0041-G, E9-0042-G, ES-0002-G, ES-0003-G, ES-0013-G, ES-0014-G, ES-0015-G, ES-0016-G, ES-0018-G, ES-0020-G, ES-0021-G, ES-0023-G, ES-0024-G, ES-0025-G, ES-0026-G, ES-0027-G, ES-0028-G, ES-0031-G, ES-0032-G, ES-0033-G, ES-0034-G, ES-0035-G, ES-0040-G, ES-0041-G, ES-0042-G, ES-0043-G, ES-0044-G, ES-0081-G, ES-0082-G, ES-0083-G, ES-0084-G, ES-0085-G, ES-0086-G.

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Medical Device Recall: Z-0041-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer