Skytron

Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.

Ergon 2 Articulating Equipment Boom Monitor Brackets || mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx).

General and Plastic Surgery Devices

2

No

Nationwide and Canada.

Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.

Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx).

General and Plastic Surgery Devices

2

No

Nationwide and Canada.

Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx).

General and Plastic Surgery Devices

2

No

Nationwide and Canada.

Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL.

Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB).

General and Plastic Surgery Devices

2

No

Nationwide and Canada.

Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)