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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GE Healthcare/General Electric Company 16-Nov-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7115
FAX: (612) 334-4142


November 16, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 08 - 04

Joseph M. Hogan
President and Chief Executive Officer
GE Healthcare / General Electric Company
3000 N. Grandview Boulevard, W-426
Waukesha, Wisconsin 53188-1615

Re: Field Test Numbers GI-80120 and GI-80121

Dear Mr. Hogan:

On September 27, 2007, a representative from the Food and Drug Administration's (FDA) New Orleans District conducted field tests of two certified diagnostic x-ray systems at the following facility:

[redacted]

X-Ray Control Manufacturer: GE Medical System
Room #R&Fl: X-Ray Control Model/ Serial No.: 5173644-2 / 1012306WK5
Room #R&F2: X-Ray Control Model/ Serial No.: 5173644-2 / 1012319WK8

Our records indicate that your firm (GE Med Systems, N25 W23255 Paul Road, Pewaukee, WI 53072) assembled these systems via the following FDA-2579 records:

Room R&F1 - G166781, dated 8/20/07
Room R&F2 - G166418, dated 8/20/07

We tested this system to determine its compliance with portions of the Performance Standard for Diagnostic X-Ray Equipment (21 CFR 1020.30-32). Diagnostic x-ray equipment is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

  • During testing in both rooms on September 27, 2007, x-ray production was possible when the primary protective barrier was not in position to intercept the x-ray beam as required by 21 CFR 1020.32(a).

We request that you, as the responsible assembler, investigate the deviation from the performance standard and/or the defect listed above in accordance with 21 CFR 1003 and 1004, as follows:

1. If you determine that the deviation and/or defect is caused by improper assembly or installation, you should correct the deviation and/or defect at no charge: to the user by either repairing the system, replacing it, or refunding the cost.

2. If you determine that the deviation and/or defect is caused by the factory-based manufacturer, you should notify the manufacturer of the deviation and/or defect and send documentation of such notification to this office.

3. If you can establish that the system is compliant, that the alleged deviation and/or defect does not exist or does not relate to the safety of the product, or is directly attributable to user abuse or lack of maintenance, you may submit such evidence to this office in accordance with 21 CFR 1003.11(a)(3) within 15 days of receipt of this letter.


You are requested to report the results of your investigation and follow-up action to this office within 15 working days of the receipt of this letter. Your response should include the date that the corrective actions were completed, and a copy of the service record and/or other supportive documents.

Failure to respond constitutes a violation of the Act, sections 538(a)(2) and 538(a)(4) of Sub-chapter C - Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968). Failure to promptly correct this violation can result in regulatory action being initiated by FDA without further notice. These actions include seizure, injunction, and the imposition of civil penalties as provided for in section 539 of the Act. Persons violating section 538 of the Act are subject to civil penalties of up to $1,000 per violation and up to a maximum of $300,000.

Your response should be sent to Thomas W. Garvin, Radiological Health Specialist, Food and Drug Administration, 2675 N. Mayfair Road., Suite 200, Milwaukee, WI 53226-1305. If you have any questions, please contact Mr. Garvin at (414) 771-7167 x 12.


Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District