§1003.10. Discovery of defect or failure of compliance by manufacturer; notice requirements. — Inbound Citations

(ii) Either immediately report incidents not associated with a death or serious injury individually or compile such incidents for submission in a quarterly summary report with tracking and trending analysis of that data in accordance with paragraphs (a) and (b) of this section. The quarterly report must cover information required under paragraphs (b)(1) through (7) of this section for each occurrence were known to the manufacturer. Occurrences may be grouped to identify the most common circumstances and potential cause(s), including but not limited to, design changes, manufacturing, or user. Planned mitigation(s) with an assessment of effectiveness, or a justification for why mitigation is not necessary, must be associated with each occurrence or grouping of similar occurrences. A manufacturer need not file a separate report under this section if an incident involving an accidental radiation occurrence is associated with a defect or noncompliance and is reported pursuant to § 1003.10 of this chapter.

The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:

(c) If, after the expiration of the period of time specified in the notice, the Secretary determines that the product has a defect or does not comply with an applicable Federal standard and the manufacturer has not applied for an exemption, he shall direct the manufacturer to furnish the notification to the persons specified in § 1003.10(b) in the manner specified in § 1003.21. The manufacturer shall within 14 days from the date of receipt of such directive furnish the required notification.

(a) The notification to the persons specified in § 1003.10(b) shall be in writing and, in addition to other relevant information which the Secretary may require, shall include:

(1) The information prescribed by § 1003.20 (a), (d), and instructions with respect to the use of the product pending the correction of the defect;

(2) A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply; and

(a) A manufacturer may at the time of giving the written confirmation required by § 1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to § 1003.11(a), apply for an exemption from the requirement of notice to the persons specified in § 1003.10(b).

(a) If any electronic product fails to comply with an applicable Federal standard or has a defect and the notification specified in § 1003.10(b) of this chapter is required to be furnished, the manufacturer of such product shall;

(1) Without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied; or

(2) Replace such product with a like or equivalent product which complies with each applicable Federal standard and which has no defect relating to the safety of its use; or

(h) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at his expense, will repair the electronic product involved,

(2) Of the method by which the manufacturer will obtain access to or possession of the product to make such repairs,

(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with making such repairs, and

(4) Of the manner in which such reimbursement will be effected.

(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products repaired.

(h) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at its expense, will replace the electronic product involved,

(2) Of the method by which the manufacturer will obtain possession of the product and effect the replacement,

(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with effecting such replacement, and

(4) Of the manner in which such reimbursement will be made.

(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products replaced.

(g) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;

(1) That the manufacturer, at his expense, will refund the cost of the electronic product plus any transportation costs,

(2) Of the amount to be refunded exclusive of transportation costs,

(3) Of the method by which the manufacturer will obtain possession of the product and make the refund.