Trumpf Medical Systems, Inc.

The operating tables which are operated with the affected remote controls (all serial numbers): Mobile column JUPITER System U, Material no. 4500113; Mobile column JUPITER System Miyabi U, Material no. 1574977; Operating table column JUPITER SM 360 U, Material no. 1389824; Operating table column JUPITER SF U OCE, Material no. 1622774; Stationary column JUPITER System U, Material no. 4500112; FLOOR MOUNTING COLUMN JUPITER U, Material no. 1276277; Floor mounting column JUPITER 360 U, Material no.1389826; Operating table JUPITER UNIVERSAL U, Material no. 4500170; OR-TABLE JUPITER UNIVERSAL CARBON U, Material no.1223188.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.

IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, Description: Federarm 3kg, 3 polig (Swing); 0376289, Federarm 12-18kg, 5-polig Kamera eco; 0376290, Federarm TFT Stop AC 2000, 9-15kg; 0376291, Federarm TFT Stop AC 3000, 12-18kg; 0376292, Federarm TFT Stop Space bis 30kg; 0376293, Federarm 3-polig NRH; 0376294, Federarm 5-polig NRH; 0376295, Federarm 3-polig NRH gerader Abgang; 0376296, Federarm 5-polig NRH gerader Abgang; 0379528, FA AC3000, Stop 7-11KG; 0385719, FA AC 2000 NRH mobil 3p, 12-18kg NG; 1387323, Federarmsicherungssegment AC3000; 1387324, Federarmsicherungssegment AC2000; 1388338, Federarm 12-18 kg 3 polig, HEL2; 1388339, Federarm 12-18 kg 5 polig HEL2; 1388340, Federarm 12-18 kg 9 polig (HELION); 1408906, FA AC2 Stop max 11kg; 1471010, FA AC2000 3p, 12-18kg; 1471011, FA AC2000 Stop 12-18kg; 1471012, FA AC2000 NRH 3p, 12-18kg; 1471013, FA AC2000, 7p, 12-18kg; 1471014, FA AC2000 NRH 7p, 12-18kg; 1471015, FA AC3000 3p, 23-30kg; 1471016, FA AC2000 Stop 6-11kg; 1471017, FA AC2000 TruVidia 7p, 3,5-7kg; 1471018, FA AC2000 Stop 3,5-7kg; 1471351, FA AC3000 NRH 3p, 23-30kg; 1502084, FA AC2 NRH f¿r HEL2, 3POL.; 1504731, Federarm 9-POLIG NRH HEL2; 1507085, (R)FEDERARM AC2000; 1645860, FA AC 2000 NRH mobil 7p, 12-18kg NG; 1645861, FA AC 2000 NRH 7p, 12-18kg NG; 1649687, FA AC 2000 SlimLine STOP, 12-18kg; 1649872, FA AC 2000 SlimLine 3p, 12-18kg; 1649997, Deckenrohr 2f Slimline 1000; 1774143, Ausleger AC2000, 750mm, 3p; 1982310, FA AC2000 MAVIG Protegra2 6-11kg; 1982311, FA AC2000 MAVIG Protegra2 12-18kg; 1982312, FA AC2000 3p, 13,5-21kg; 1982313, FA AC2000 NRH 3p, 13,5-21kg; 4024211, Federarm AC2000; 4024212, FA AC2 Stop; 4024213, FA AC3; 4024214, FA AC3000 Stop, 12-18kg; 4024215, FA AC5000 Stop; 4024651, FA AC3000, 7p; 4024652, FA AC2 3K; 024848, Federarm AC3000 NRH; 4025574, FA AC3000 Stop 23-30 kg; 4025575, FA AC5000 Stop max 15 kg; 4025576, FA AC2 K TruVidia; 8800900, Federarm HELION L+ 12,5 kg 5-polig; 8800901, Federarm HELION M+ 12,5 kg 3-polig; 8800905, Federarm HEL L/L+, 11,4 kg 3-polig; 8800906, Federarm HELION M NRH; 8800907, Federarm FA 77 V 11,4 kg 3 polig; 8800908, Federarm FA 77 V 6,8 kg 3 polig; 8800909, Federarm f¿r L-Leuchte So-Version; 8800910, Federarm f¿r M-Leuchte So-Version; 8800911, Federarm FA 77 V 13 kg 3 polig; 8800915, Federarm FA 77 N 11,4 kg5 polig; 8800916, Federarm FA 77 N 6,8 kg 5 polig; 8800919, Federarm FA 77 N 13 kg 5 polig; 8800920, Federarm FA 77 N 8,9 kg 5 polig; 8800925, Federarm FA 77 N 11,4 kg 7 polig; 8800926, Federarm Helion M NRH 7-polig; 8800929, Federarm FA 77 N 13 kg 7 polig; 8800930, Federarm FA 77 N 8,9 kg 7 polig; 8801000, Federarm HELION M+ 8.3 kg 5-polig; 8801001, Federarm HELION M+ 8,3 kg 3-polig; 8801007, Federarm AC 2000, 9-15 kg O. Elektrik; 8801008, Federarm AC 2000, 7-12 kg 5 polig; 8801009, Federarm AC 2000, 12-18 kg 5 polig; 8801010, Federarm Acrobat 2000 12-18 kg; 8801011, Federarm; 8801012, Federarm AC 2000 7-15 kg 3 polig mit; 8801013, Federarm AC 2000, 9-15 kg 7 polig; 8801014, Federarm f¿r Helion M; 8801015, Federarm AC 2000, 1-3,5 kg 7 polig; 8801016, Federarm AC2000 9-15 kg 5-polig; 8801017, Federarm HELION S Mobile; 8801018, Federarm AC 2000, 12-18 kg 3 polig; 8801019, Federarm AC 2000, 1-3,5 kg 3 polig; 8801020, Federarm AC 2000, 12-18 kg 7 polig; 8801021, Federarm AC 2000, 1-3,5KG, Adapt. Anschl; 8801033, Federarm Deckenanschlu¿ HELS; 8801050, Federarm AC 3000, 12-18 kg ohne Elektr.; 8801051, Federarm SPACE 20-40 kg ohne Elektrik; 8801101, Federarm SWING 2-3 kg 3 POL. 120 Volt; 8801102, Federarm SWING 2-3 kg 3 POL. 230 Volt; 8801103, Federarm f¿r HELION S; 8801104, Federarm SWING 2-3 kg 3 polig; 8807200, Federarm 6.5kg f¿r HELION M+ Mobile; 8894025, Federarm WA 77, 8,3 kg 3 polig; 1425487, FA AC2 STOP 3,5KG - MAX 7KG; 1768718; FA AC 77, NRH 3P; 0385246, FA AC2000 NRH 3P, 12-18KG; 4024790, FA AC3000 NRH 7P; 1419354, FA AC3000 STOP (17 -26KG); 0384021, FA AC2000 NRH MOBIL 3P 12-18KG; 0385247, FA AC2000 NRH MOBIL 7P, 12-18KG; 1695239, ACHSE 1F WL 800, 3P + FA SWING; 1695224, ACHSE 1F ZA 800, 3P + FA SWING; 1886331, BEFESTIGUNGSSET FA AC 77/2000/SWING; and Material #1695225, Description: STATIV MOBIL TL1000, 3P + FA SWING.

General and Plastic Surgery Devices

2

No

Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)

General and Plastic Surgery Devices

2

No

USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.

Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). || The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.

Serial Numbers - 101281354, 101856082, 101858789, 101858794, 101861232, 101871990, 101871991, 101871994, 101871995, 101871998, 101872002, 101872003, 101875823, 101884649, 101884662, 101890660, 101890661, 101890683, 101895634, 101912771, 101912832, 101912833, 101912837, 101912838, 101916174, 101924149, 101863428, 101875818, 101882033, 101882034, 101882037, 101882038, 101901949, 101901951, 101904490, 101904492, 101907204, 101907205, 101909370, 101909371, 101909372, 101909464, 192052657

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system