Inspections, Compliance, Enforcement, and Criminal Investigations
General Electric Company-Medical System 31-Oct-02
Department of Health and Human Services
Public Health Service
4040 N. Central Expressway #900
October 31, 2002
Return Receipt Requested
Re: Field Test No. GI71132
Room No. X-ray
Control S/N [redacted]
Model No. [redacted]
William A. Gibson
Field Service Compliance Coordinator
General Electric Company-Medical Systems
N25 W23255 Paul Road
Pewaukee, WI 53072
Dear Mr. Gibson:
On September 17, 2002,a representative from the Food and Drug Administration conducted a field test on the above referenced x-ray equipment. This system, installed by your firm on April 19, 2002 as reported by Form FDA 2579, GI36892, was tested to determine its compliance with applicable portions of the Performance Standards for Diagnostic X-ray Equipment, Title 21,Code of Federal Regulations (C.F.R.), Part 1020. Analysis of the data obtained indicates that the following item was not in compliance with the standard:
X-ray production was possible with the primary protective barrier in the park position (outside of the primary x-ray beam). This is in violation of 21 C.F.R. § 1020.32(a)(1).
We request that you, as the responsible assembler, investigate the deviation from the performance standard cited above in accordance with 21 C.F.R. §§ 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 noncompliance 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 him of the noncompliance 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 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 in accordance with 21 C.F.R. § 1003.30 within thirty (30) working days of receipt of this letter.
You must report the results of your investigation and follow-up actions to this office within 30 working days of receipt of this letter. Your response should include the date that the corrective action was completed and copies of service records and/or supportive documents. If you do not respond within 30 working days, the FDA may consider you to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), sections 538(a)(2) and 538(a)(4) (21 U.S.C. §§360oo(a)(2) and(a)(4)) of Subchapter C-Electronic product Radiation Control (formerly) the Radiation Control for Health and Safety Act of 1968).
Please note that improper installation, including failure to follow installation instructions which cause the system to be noncompliant with the Performance Standard may cause the system to be an adulterated device. Under 501(c) (21 U.S.C, § 351(c)) of the Act the system would not be of a quality represented by the labeling (including the certification statement).
Failure to promptly correct these violations can result in regulatory action being initiated by the
Food and Drug Administration without further notice. These actions include seizure and/or
injunction and/or the imposition of civil penalties as provided for in section 539(21 U.S.C.
360pp) of the Act. Persons violating section 538 (21 U.S.C. § 360oo) of the Act are subject
to civil penalties of up to $1,000 per violation and up to a maximum of $3,00,000.
You should notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to Deborah M. McGee, Radiation
Specialist, Food and Drug Administration; 4040N. Central Expressway #900, Dallas, TX 75204-3158. If you have any questions regarding the results of the referenced field test, or related to technical matters, you may contact Ms. McGee at (214) 253-4935.
Gary L. Pierce
Regional Food and Drug Director