Philips Medical Systems

Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit  M8040A option E22 Quick release kit for MP20MP30  A list of S/N's can be obtained fromthe recalling firm.

Cardiovascular Devices

2

No

Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, Slovenia South Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia

Philips M8000-64100 Table Mount || Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. || Product shipped between 6/03/08 and 9/12/08 as follows: || M1013A IntelliVue G1 Gas Module || M1019A IntelliVue GS Gas Module || M8001A option E22 Quick release mount for IntelliVue MP20 || M8002A option E22 Quick release mount for IntelliVue MP30 || M8003A IntelliVue MP40 || M8004A IntelliVue MPSO || M8005A IntelliVue MP60 || M8007A IntelliVue MP70 || M8105A option E22 IntelliVue MP5 Quick Release Mount || M8105AT option E22 IntelliVue MPST Quick Release Mount || M8040A option U02 U02 Table top mount kit || M8040A option E22 Quick release kit for MP20MP30 || The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.

M3811B software revision identified as Build 1.1.2.11d, B.02.07.

Anesthesiology Devices

2

No

Nationwide

M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.

Serial Numbers:  US10603477 US60711180 US70711234 US80711276 US80711348 US80711386 US80711459 US10603478 US60711181 US70711235 US80711283 US80711349 US80711387 US80711460 US10603491 US60711182 US70711236 US80711284 US80711350 US80711388 US80711461 US10603493 US60711183 US70711241 US80711285 US80711351 US80711389 US80711462 US10603494 US60711184 US80503039 US80711286 US80711352 US80711390 US80711463 US10603495 US60711185 US80503049 US80711287 US80711353 US80711391 US90503082 US10603496 US60711186 US80711244 US80711288 US80711354 US80711392 US90503117 US10603497 US70711197 US80711245 US80711289 US80711355 US80711393 US90503119 US10603498 US70711199 US80711246 US80711290 US80711356 US80711394 US90503120 US10603499 US70711201 US80711247 US80711291 US80711357 US80711395 US90503121 US10603530 US70711205 US80711248 US80711292 US80711358 US80711396 US90503126 US10710463 US70711207 US80711249 US80711293 US80711359 US80711398 US90503127 US10710464 US70711208 US80711250 US80711294 US80711360 US80711399 US90503128 US10710465 US70711209 US80711251 US80711295 US80711361 US80711400 US90503129 US50502760 US70711210 US80711252 US80711296 US80711362 US80711402 US90503143 US50710968 US70711211 US80711253 US80711297 US80711363 US80711403 US90503148 US60502824 US70711212 US80711254 US80711298 US80711364 US80711404 US90503149 US60502825 US70711213 US80711255 US80711299 US80711365 US80711405 US90503150 US60502826 US70711214 US80711256 US80711300 US80711366 US80711406 US90503151 US60711064 US70711215 US80711257 US80711301 US80711367 US80711407 US90503152 US60711065 US70711216 US80711258 US80711302 US80711368 US80711408 US90503153 US60711067 US70711217 US80711259 US80711303 US80711369 US80711409 US90503154 US60711068 US70711218 US80711260 US80711304 US80711370 US80711411 US90503155 US60711070 US70711219 US80711261 US80711305 US80711371 US80711412 US90503156 US60711071 US70711220 US80711262 US80711306 US80711372 US80711413 US90503157 US60711073 US70711221 US80711263 US80711307 US80711373 US80711416 US90503158 US60711074 US70711222 US80711264 US80711308 US80711374 US80711417 US90503159 US60711075 US70711223 US80711265 US80711309 US80711375 US80711418 USD0301315 US60711076 US70711224 US80711266 US80711310 US80711376 US80711419 USD0610313 US60711077 US70711225 US80711267 US80711339 US80711377 US80711420 USN0301134 US60711078 US70711226 US80711268 US80711340 US80711378 US80711421 USN0400155 US60711079 US70711227 US80711269 US80711341 US80711379 US80711422 USN0402121 US60711080 US70711228 US80711270 US80711342 US80711380 US80711431 USN0402126 US60711081 US70711229 US80711271 US80711343 US80711381 US80711439 USN0402127 US60711176 US70711230 US80711272 US80711344 US80711382 US80711440 USN0402128 US60711177 US70711231 US80711273 US80711345 US80711383 US80711455 USN0402129 US60711178 US70711232 US80711274 US80711346 US80711384 US80711457 USN0610295 US60711179 US70711233 US80711275 US80711347 US80711385 US80711458 and USO0610104

Cardiovascular Devices

2

No

Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.

Philips PageWriter Touch Cardiograph, || Model: 860284, Philips Medical Systems, Andover, MA, 01810

S/N's: Lot numbers(s) or serial number(s) US00453446 US00453452 US00453458 US00453459 US00453460 US00453461 US00453463 US00453465 US00453466 US00453471 US00453472 US00453475 US00453477 US00453479 US00453486 US00453487 US00453488 US00453489 US00453490 US00453491 US00453492 US00453513 US00453514 US00453515 US00453516 US00453517 US00453541 US00453542 US00453543 US00453544 US00453545 US00453546 US00453547 US00453548 US00453549 US00453550 US00453552 US00453553 US00453564 US00453565 US00453566 US00453596 US00453597 US00453598  US00453599 US00453601 US00453602 US00453603 US00453604 US00453607 US00453609 US00453610 US00453611 US00453613 US00453614 US00453615 US00453616 US00453617 US00453618 US00453619 US00453621 US00453622 US00453623 US00453624 US00453631 US00453634 US00453635 US00453636 US00453637 US00453638 US00453640 US00453641 US00453642 US00453645 US00453646 US00453647 US00453648 US00453649 US00453650 US00453651 US00453652 US00453653 US00453654 US00453655 US00453656 US00453657 US00453658 US00453659  US00453660 US00453661 US00453662 US00453663 US00453664 US00453666 US00453667 US00453668 US00453669 US00453670 US00453671 US00453672 US00453673 US00453674 US00453675 US00453676 US00453677 US00453678 US00453679 US00453691 US00453692 US00453693 US00453694 US00453695 US00453696 US00453712 US00453714 US00453715 US00453716 US00453717 US00453721 US00453723 US00453724 US00453725 US00453726 US00453730 US00453731 US00453732 US00453733 US00453734 US00453735 US00453736 US00453737 US00453738  US00453739 US00453740 US00453742 US00453744 US00453745 US00453746 US00453747 US00453748 US00453749 US00453751 US00453752 US00453753 US00453754 US00453755 US00453758 US00453759 US00453760 US00453766 US00453767 US00453796 US00453797 US00453798 US00453799 US00453800 US00453801 US00453802 US00453803 US00453804 US00453805 US00453806 US00453807 US00453808 US00453809 US00453810 US00453811 US00453812 US00453813 US00453814 US00453815 US00453816 US00453817 US00453818 US00453819 US00453820  US00453821 US00453822 US00453823 US00453824 US00453825 US00453826 US00453827 US00453828 US00453829 US00453830 US00453831 US00453832 US00453833 US00453834 US00453835 US00453836 US00453847 US00453849 US00453850 US00453852 US00453853 US00453854 US00453855 US00453856 US00453857 US00453861 US00453863 US00453864 US00453865 US00453866 US00453867 US00453868 US00453869 US00453870 US00453871 US00453872 US00453873 US00453874 US00453907 US00453908 US00453909 US00453910

Cardiovascular Devices

3

No

Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany

HeartStart XL Defibrillator/Monitor, Model: M4735A

Units with software versions A.02.00 or greater

Cardiovascular Devices

3

No

NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK

Model M4735A HeartStart XL Defibrillator//Monitor