| Class 2 Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. | |
Date Initiated by Firm | August 30, 2013 |
Date Posted | October 17, 2013 |
Recall Status1 |
Terminated 3 on May 22, 2014 |
Recall Number | Z-0012-2014 |
Recall Event ID |
66277 |
510(K)Number | K011624 K081091 K760466 K801320 K973039 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
|
Product | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. |
Code Information |
Serial # System ID 00000976624WK7 202884RF2410 00000977748WK3 202884RF2411 00000955594WK7 205877LRF2 00000965983WK0 207373RF1 00000969026WK4 215748LEG1 00000960066WK9 219416ADV 00000975683WK4 228809SR2 00000966338WK6 256235ORF1 00000967770WK9 301896RF 00000961102WK1 302654RF 00000972383WK4 303440BCHRM4 00000964398WK2 303730R3 00000958345WK1 304256RX1A 00000978812WK6 361552LEGD1 00000970377WK8 404321LEG2 00000973016WK9 408259RF1 00000963305WK8 408977RF5 00000963524WK4 414266RM03 00000963118WK5 417533BR2 00000969537WK0 507372LEG 00000959491WK2 518382SRM2 00000976668WK4 540862ARF6 00000966773WK4 561468RM4 00000972380WK0 606285LEGACY 00000966622WK3 619421RF1 00000957841WK0 708216GIRF1 00000983335WK1 713527PRF1 00000964482WK4 775738RM2 00000971676WK2 804289HDF4 00000978181WK6 804747DHP1 00000994573WK4 815740RF1 00000961772WK1 817472LEG1 00000963293WK6 850747ER1 00000975653WK7 856778RF2 00000965747WK9 864295GRRM4 00000973832WK9 904508LEGACY 00000962333WK1 904819RF1 00000970009WK7 907276RM3 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Available 416284LS16 Not Available 506648L9A Not Available 514934BRAD3 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle.
There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p |
FDA Determined Cause 2 | Employee error |
Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found.
1. If you observe that the power assist handle plastic grip is loose relative to
the mount, discontinue use.
2. If plastic grip is secure, but you observe erratic performance, (power assist
unresponsive, drifting of spotfilm device with no command, or lock release
always ON), you may continue to use the device with care. Use all safety
precautions relative to application of the myelographic stop and the inhibit,
table horizontal stop OFF.
GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please call one of the following phone numbers:
United States: 800 437 1171
Japan: 0120 055 919
For other countries, please contact your local GE Healthcare Service Representative
. |
Quantity in Commerce | 810 (783 US, 27 OUS) |
Distribution | Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAA 510(K)s with Product Code = JAA 510(K)s with Product Code = JAA
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