SFDA Alerted
of the need to replace the electrical wiring of "hoffrichter GmbH" devices
that help to prevent sleep apnea, for models (Trend 2, Point, and Victor-it).
SFDA
noted in a statement, that some complaints were received by the company about
cuts in the protective insulation of the electrical wire socket resulting in
exposure of internal wire which may lead electric shock.
SFDA
recommended to replace all defective electrical wiring of "hoffrichter
GmbH" devices, Model (Trend 2, Point, and Victor-it), manufactured in the
period from January 2007 till December 2013 with new electric cables free of
charge to avoid the risk of electric shock, noting that individuals who have affected devices shall contact the local
distributor Bait Nahawand company at phone number (0114831985).
SFDA
called on consumers to report problems
related to medical devices and products, by visiting the website of the
National Center for Medical Devices Reports
at: http://ncmdr.sfda.gov.sa
SFDA
reported that the electric cable number is: 31100015, and the serial numbers of
affected devices are:
Serial Numbers | |||||
J07H0965 |
J08G3076 |
J08M3996 |
J10C5634 |
J10C5836 |
BDJ0900343 |
AFF0700006 |
J08G3077 |
J08M3997 |
J10C5635 |
J10C5837 |
BDJ0900344 |
ALF0700005 |
J08G3078 |
J08M3998 |
J10C5636 |
J10C5838 |
BDJ0900345 |
AFB0800132 |
J08G3082 |
J08M3999 |
J10C5637 |
J10C5839 |
BDJ0900346 |
AFB0800133 |
J08G3086 |
J08M4000 |
BBB1002919 |
BEE1000589 |
BCJ1001463 |
AFB0800134 |
J08G3112 |
J08M4001 |
BBB1002920 |
BEE1000593 |
BCJ1001464 |
AFB0800135 |
AII0800219 |
J09D4738 |
BBB1002921 |
BEE1000596 |
BCJ1001465 |
AFB0800136 |
AII0800220 |
J09D4739 |
BBB1002922 |
BEE1000598 |
BCJ1001466 |
AFB0800137 |
AII0800221 |
J09D4740 |
BBB1002923 |
BEE1000599 |
BDD1000370 |
AFB0800140 |
AII0800222 |
J09D4741 |
BBB1002924 |
BCE1001062 |
BDD1000371 |
AFB0800141 |
AII0800223 |
J09D4742 |
BBB1002925 |
BCE1001063 |
BDD1000372 |
AIB0800072 |
AII0800224 |
J09D4743 |
BBB1002926 |
BCE1001064 |
BDD1000373 |
AIB0800073 |
AII0800225 |
J09D4744 |
BBB1002927 |
BCE1001085 |
BDD1000374 |
AIB0800074 |
AII0800226 |
J09D4745 |
BBB1002928 |
BCE1001086 |
BDD1000375 |
AIB0800075 |
AII0800227 |
J09D4747 |
AIJ0900808 |
BDE1000384 |
BDD1000376 |
AIB0800076 |
AII0800228 |
J09D4748 |
AIJ0900809 |
BDE1000385 |
BDD1000377 |
ALL0700054 |
J08L3887 |
BDI0900222 |
AIJ0900810 |
BDE1000386 |
BDD1000378 |
ALA0800079 |
J08L3906 |
BDI0900223 |
AIJ0900811 |
BDE1000387 |
BDD1000379 |
J08B1999 |
J08L3924 |
BDI0900224 |
AIJ0900812 |
BDE1000388 |
BDD1000380 |
J08B2000 |
J08L3939 |
BDI0900225 |
BDI0900263 |
BDE1000389 |
BDD1000381 |
J08B2001 |
J08L3940 |
BDI0900226 |
BDI0900264 |
BDE1000390 |
BDD1000382 |
J08B2002 |
J08M3944 |
BDI0900227 |
BDI0900265 |
BDE1000391 |
BDD1000383 |
J08B2003 |
J08M3945 |
BDI0900228 |
BDI0900266 |
BDE1000392 |
BDE1000394 |
J08B2004 |
J08M3946 |
BDI0900229 |
BDI0900267 |
BDE1000393 |
J10K6461 |
J08B2005 |
J08M3947 |
BDI0900230 |
BDI0900268 |
J10C5728 |
J10K6462 |
J08B2006 |
J08M3948 |
BDI0900231 |
BDI0900269 |
J10E6059 |
J10K6463 |
J08B2007 |
AIM0800306 |
J10B5618 |
BDI0900271 |
J10E6060 |
J10K6464 |
J08B2008 |
AIM0800307 |
J10B5619 |
BDI0900274 |
J10E6061 |
J10K6467 |
AIE0800162 |
AIM0800308 |
J10B5620 |
BDI0900275 |
J10E6062 |
J10K6469 |
AIE0800163 |
AIM0800309 |
J10B5621 |
BDJ0900305 |
J10I6270 |
J10K6470 |
AIE0800164 |
AIM0800310 |
J10B5622 |
BDJ0900306 |
J10I6271 |
J10K6471 |
AIE0800165 |
BDI0800016 |
J10B5623 |
BDJ0900307 |
J10I6272 |
J10K6468 |
AIE0800166 |
BDI0800019 |
J10B5624 |
BDJ0900308 |
J10I6273 |
J10K6472 |
AIE0800167 |
BDI0800022 |
J10B5627 |
BDJ0900309 |
J10I6274 |
J10K6473 |
AIE0800168 |
BDL0800023 |
J10B5628 |
AIK0900849 |
J10I6275 |
J10K6474 |
AIE0800169 |
BDL0800024 |
J10B5629 |
AIK0900850 |
J10I6276 |
J10K6475 |
AIE0800170 |
BDL0800025 |
J10C5630 |
AIK0900851 |
J10I6277 |
J10K6476 |
AIE0800171 |
BDL0800026 |
J10C5631 |
AIK0900852 |
J10I6278 |
J10K6477 |
J08G3074 |
J08M3994 |
J10C5632 |
AIK0900853 |
J10I6279 |
J10K6478 |
J08G3075 |
J08M3995 |
J10C5633 |
J10C5835 |
BDJ0900342 |
J10K6479 |
J10K6480 |
BDI1000409 |
J11D7311 |
BDD1100702 |
J11K7992 |
BEI1101215 |
J10K6481 |
BDI1000410 |
J11D7312 |
BDD1100703 |
J11K7993 |
BEI1101216 |
J10K6482 |
BDI1000411 |
J11D7313 |
BDD1100704 |
J11K7994 |
BDB1200838 |
J11A6685 |
J11C6965 |
J11D7314 |
BDD1100705 |
J11K7995 |
BDB1200839 |
J11A6686 |
J11C6966 |
J11D7315 |
BDD1100706 |
J11K7996 |
BDB1200840 |
J11A6687 |
J11C6967 |
J11D7316 |
BDD1100707 |
BEH1101170 |
BDB1200841 |
J11A6688 |
J11C6968 |
J11D7317 |
BDD1100708 |
BEH1101171 |
BDB1200842 |
J11A6689 |
J11C6969 |
J11D7318 |
BDD1100709 |
BEH1101172 |
BDB1200843 |
J11A6690 |
J11C6970 |
J11D7319 |
BEB1100966 |
BEH1101173 |
BDB1200844 |
J11A6691 |
J11C6971 |
J11D7320 |
BEB1100967 |
BEH1101174 |
BDB1200845 |
J11A6692 |
J11C6972 |
J11D7321 |
BSH1100007 |
BCA1202452 |
BDB1200846 |
J11A6693 |
J11C6973 |
J11D7322 |
J11F7698 |
BCA1202453 |
BDB1200847 |
J11A6694 |
J11C6975 |
J11D7323 |
J11F7699 |
BCA1202454 |
BDB1200848 |
J11A6695 |
J11C6987 |
J11D7324 |
J11F7700 |
BCB1202583 |
BDB1200849 |
J11A6696 |
J11C6988 |
J11D7325 |
J11F7701 |
BCB1202584 |
BDB1200850 |
J11A6697 |
J11C6989 |
BBD1105525 |
J11F7702 |
BCB1202585 |
BDB1200851 |
J11A6698 |
J11C6990 |
BBD1105526 |
J11F7703 |
BCB1202586 |
BDB1200852 |
J11A6699 |
J11C6991 |
BBD1105527 |
J11F7704 |
BCB1202587 |
BDB1200853 |
J11A6700 |
J11C6992 |
BBD1105528 |
J11F7705 |
BCB1202588 |
BDB1200854 |
J11A6701 |
J11C6993 |
BBD1105529 |
J11F7706 |
BCB1202589 |
BDB1200855 |
J11A6702 |
J11C6994 |
BEL1000929 |
J11F7707 |
BCB1202590 |
BDB1200856 |
J11A6703 |
J11C6995 |
BEL1000930 |
BDH1100735 |
BCB1202591 |
BDD1200877 |
J11A6704 |
BEL1000826 |
BBD1105530 |
BDH1100736 |
BCB1202592 |
ALJ1100563 |
J11A6725 |
BEL1000827 |
BBD1105531 |
BDH1100737 |
BDK1100804 |
BDJ1200939 |
J11A6726 |
BEL1000828 |
J11D7395 |
BDH1100738 |
BDK1100805 |
BDJ1200940 |
J11A6727 |
BEL1000829 |
J11D7396 |
BDH1100739 |
BDK1100806 |
BDJ1200941 |
J11A6728 |
BEL1000830 |
J11D7397 |
J11K7977 |
BDK1100807 |
BDJ1200942 |
J11A6729 |
BCC1101712 |
J11D7398 |
J11K7978 |
BDK1100808 |
BDJ1200943 |
J11A6730 |
BCC1101713 |
J11D7399 |
J11K7979 |
BDK1100809 |
BEJ1201442 |
J11A6731 |
BCC1101714 |
J11D7400 |
J11K7980 |
BDK1100810 |
BEJ1201453 |
J11A6732 |
BCC1101715 |
J11D7401 |
J11K7981 |
BDK1100811 |
BEJ1201454 |
J11A6733 |
BCC1101716 |
J11D7402 |
J11K7982 |
BDK1100812 |
BEJ1201455 |
J11A6734 |
J11D7412 |
J11D7403 |
J11K7983 |
BDK1100813 |
BEJ1201456 |
BDE1000400 |
J11D7413 |
J11D7404 |
J11K7984 |
BDK1100814 |
BDK1200981 |
BDE1000401 |
J11D7414 |
J11D7405 |
J11K7985 |
BDK1100815 |
BDK1200982 |
BDE1000402 |
BDD1100695 |
J11D7406 |
J11K7986 |
BDK1100816 |
BDK1200983 |
BDE1000403 |
BDD1100696 |
J11D7407 |
J11K7987 |
BDK1100817 |
BDK1200984 |
BDE1000404 |
BDD1100697 |
J11D7408 |
J11K7988 |
BDK1100818 |
BDK1200985 |
BDE1000405 |
BDD1100698 |
J11D7409 |
J11K7989 |
BEI1101212 |
BDK1200986 |
BDI1000408 |
BDD1100699 |
J11D7410 |
J11K7990 |
BEI1101213 |
BDK1200987 |
BDD1100701 |
BDD1100700 |
J11D7411 |
J11K7991 |
BEI1101214 |
BDK1200988 |
BDK1200989 |
BDA1301033 |
BDB1301076 |
BDH1301132 |
BDJ1301183 |
BDH1301166 |
BDK1200990 |
BDA1301035 |
BDB1301077 |
BDH1301133 |
BDJ1301184 |
BDH1301167 |
BDK1200991 |
BDA1301036 |
BDB1301078 |
BDH1301134 |
BDJ1301185 |
BDH1301168 |
BDK1200992 |
BDA1301037 |
BDE1301094 |
BDH1301135 |
BDK1301197 |
BEE1301557 |
BDK1200993 |
BDA1301038 |
BDE1301095 |
BDH1301149 |
BDK1301198 |
BEE1301558 |
BDK1200994 |
BDA1301039 |
BDE1301096 |
BDH1301150 |
BDK1301199 |
BEE1301559 |
BDK1200995 |
BDB1301045 |
BDE1301097 |
BDH1301151 |
BDK1301200 |
BEE1301560 |
BDK1200996 |
BDB1301046 |
BDE1301098 |
BDH1301152 |
BDK1301201 |
BEE1301561 |
BDA1301000 |
BDB1301047 |
BDG1301099 |
BDH1301153 |
BDK1301202 |
BEE1301562 |
BDA1301001 |
BDB1301048 |
BDG1301100 |
BDH1301154 |
BDK1301203 |
BEE1301563 |
BDA1301002 |
BDB1301049 |
BDG1301101 |
BDH1301155 |
BDK1301204 |
BEE1301564 |
BDA1301003 |
BDB1301050 |
BDG1301102 |
BDH1301156 |
BDK1301205 |
BEE1301565 |
BDA1301004 |
BDB1301051 |
BDG1301103 |
BDH1301157 |
BDK1301206 |
BEE1301566 |
BDA1301005 |
BDB1301052 |
BDG1301104 |
BDH1301158 |
BDB1401230 |
BDJ1301176 |
BDA1301006 |
BDB1301053 |
BDG1301105 |
BDH1301159 |
BDB1401231 |
BDJ1301177 |
BDA1301007 |
BDB1301054 |
BDG1301106 |
BDH1301160 |
BDB1401232 |
BDJ1301178 |
BDA1301008 |
BDB1301055 |
BDG1301107 |
BDH1301161 |
BDB1401233 |
BDJ1301179 |
BDA1301009 |
BDB1301056 |
BDG1301108 |
BDH1301162 |
BDB1401234 |
BDJ1301180 |
BDA1301010 |
BDB1301057 |
BDG1301109 |
BDH1301163 |
BEC1401646 |
BDJ1301181 |
BDA1301011 |
BDB1301058 |
BDG1301110 |
BDH1301164 |
BEC1401647 |
BDJ1301182 |
BDA1301012 |
BDB1301059 |
BDG1301111 |
BDH1301165 |
BEC1401648 |
BEC1401650 |
BDA1301013 |
BEL1201479 |
BDG1301112 |
BDA1301023 |
BDE1301084 |
BDH1301122 |
BDA1301014 |
BEL1201480 |
BDG1301113 |
BDA1301024 |
BDE1301085 |
BDH1301123 |
BDA1301015 |
BEL1201481 |
BDG1301114 |
BDA1301025 |
BDE1301086 |
BDH1301124 |
BDA1301016 |
BEL1201482 |
BDG1301115 |
BDA1301026 |
BDE1301087 |
BDH1301125 |
BDA1301017 |
BEB1301490 |
BDG1301116 |
BDA1301027 |
BDE1301088 |
BDH1301126 |
BDA1301018 |
BDE1301079 |
BDG1301117 |
BDA1301028 |
BDE1301089 |
BDH1301127 |
BDA1301019 |
BDE1301080 |
BDG1301118 |
BDA1301029 |
BDE1301090 |
BDH1301128 |
BDA1301020 |
BDE1301081 |
BDH1301119 |
BDA1301030 |
BDE1301091 |
BDH1301129 |
BDA1301021 |
BDE1301082 |
BDH1301120 |
BDA1301031 |
BDE1301092 |
BDH1301130 |
BDA1301022 |
BDE1301083 |
BDH1301121 |
BDA1301032 |
BDE1301093 |
BDH1301131 |
BEC1401649 |