Trumpf Medical Systems, Inc.

Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).

General and Plastic Surgery Devices

2

No

Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.

Helion and Xenion surgical lights, 501/01 series KLM lights. || The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Serial numbers: 100268621 to 100717475

General and Plastic Surgery Devices

2

No

Worldwide Distribution.

ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K

I.D. on nameplate: FA AC3 or FA AC3000; Material #1920632, Serial #011201602557 to 011201602588; Serial #011203602617 to 011202602621; Serial #011203602676 to 011203602695; Serial #011203602756 to 011203602775; Serial #011203602776 to 011203602795; Serial #011204602798 to 011204602817; Serial #011204602861 to 011204602880; Serial #011204602970 to 011204602989; Serial #011205603032 to 011205603081; Serial #011206603118 to 011206603167; Serial #011206603168 to 011206603217; Serial #011207603303 to 011207603314; Serial #011208603316 to 011205603333; Serial #011208603361 - Serial #011209603431 to 011209603462; Serial #011210603572 to 011210603597 and Material #1851710, Serial #3705776 to 3705777 and Serial #4105778 to 4105781.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada

Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Material number 1583966

General and Plastic Surgery Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MO, NC, NM, NJ, NY, OH, PA, TX, VA, VT, WA, and WI; and countries of: Australia; Austria, Belguim, China, Cyprus, Denmark, Estonia, Finland, France, Germany, Great Britain, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea, Latvia, Luxembourg, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Seychelles, Singapore, South Africa (Zuid Afirka), Spain, Sweden, Switzerland (Confederation of Helvetia), Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.

Surgical lighting systems iLED and TruLight in use with the ALC+ function. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Material number 1465166, All Serial numbers.

General and Plastic Surgery Devices

1

No

Worldwide Distribution.

OR table TITAN UT, Surgical Table. || Surgical bed with Orthopedic Accessories.