Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0042-2007

OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc

GE Healthcare / initiated 2006-09-30 / Terminated

GE OEC Medical Systems, Inc began a recall of OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc on . The reason FDA records is "X-ray system may lose or mix images and/or lose patient data". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0042-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall
X-ray system may lose or mix images and/or lose patient data.
FDA root cause
Other
Action
Consignees will be notified by letter beginning 10/21/2006.
Quantity in commerce
822 units
Distribution
Nationwide, including VA facilities in FL, NC, WA and military accounts in GA and WA. Foreign distribution to Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK.
Product codes and lots
Serial numbers: E2-0001 thru E2-0065, E2-0066-CH, E2-0067 thru E2-0152, E2-0156 thru E2-0159, E2-0166, E2-7001-MH thru E2-7033-MH, E2-7034-CMH, E2-7035-MH thru E2-7056-MH, E9-0001, E9-0003, E9-0005 thru E9-0013, E9-0015 thru E9-0031, E9-0033, E9-0034, E9-0038, E9-0039, E9-0043 thru E9-0082, E9-00084, E9-0086, E9-0087, E9-0096, E9-0097, E9-0104, E9-0105, E9-0106, E9-0107, ES-0001, ES-0004, ES-0005, ES-0006, ES-0007-C, ES-0008, ES-0009, ES-0010, ES-0011-H, ES-0012-H, ES-0017, ES-0019, ES-0022-CH, ES-0029-CH, ES-0030, ES-0036-CH, ES-0037, ES-0038, ES-0039, ES-0045-H, ES-0046-CH, ES-0047, ES-0048, ES-0049-H, ES-0050 thru ES-0059, ES-0060-H, ES-0061, ES-0062-H, ES-0063-H, ES-0064, ES-0065, ES-0066-CH, ES-0067 thru ES-0080, ES-0091-H, ES-0092-CH, ES-0093, ES-0094, ES-0095, ES-0096, ES-0099-CH, ES-0100-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0106, ES-0107, ES-7001-CMH, ES-7002-MH, ES-7003-MH, ES-7004-CMH, ES-7005-MH, ES-7006-CMH thru ES-7013-CMH, ES-7014-MH thru ES-7018-MH, ES-7019-CMH, ES-7020-CMH, ES-7022-CMH, ES-7023-CMH, ES-7024-CMH, ES-7025-CMH, ES-7026-MH, ES-7027-MH.