Stryker

Monitors

Connected OR Cart Urgent Medical Device Recall April 2019

Recall

Monitor can be installed incorrectly

1 Page

stryker 59000ptica1Court, 5an Jose... A 95138 USA It: 408· 754·2000 URGENT MEDICAL DEVICE RECALL NOTIFICATION Connected OR Cart... 20 V April 23, 2019 Acco unt Number: Device Description: Connected OR Cart, 120 V Affected Part Number: 0210-099-155 Affecte d Serial Nu m b ers: Tallie Bel ow GT IN: 076133274627B4 2019ANOOOOS 2019AN00017 2019AN00041 2019AN00048 2019AN00061 2019AN00085 2019AN00007 2019AN00039 2019J\N00046 2019ANOOOS4 2019AN00067 2019AN00087 T he pu rpose nf this nntifit:;ili on is tn :id vise yo u that St ryke1· Endoscopy is conducting a vol untary recall of the Con nected OR Cart... 20 V... ll units that have a serial nu mber li~ted a hove must Ile i11spcctcd... Reason for the Vol u ntary Recall: T he above affected Co nnected OR C:irts (0240-099 -155) h:ivc countersink hole s on the moni tor stow h;indle (7 -00 12464) on the incorrect side, whic h leads to the co untcrsi11k fasteners 110[ fitti ng nush with th e bracket... Risk to Health: As a res ult of"the coun tersink ho les being on the incorrect s ide th e re is ii pote ntial tlw monitor can he inst;illcd inco r rectly... f this occurs, chis coul d po cemia ll y lead to a haza rd o f a mo nitor fa lli ng off of the monitor s tow ha ndle a nd cm1si11g a pote ntial r isk of inj ury... :l... e... here hnve been no complnints 0 1· adve rse even ts relnte<l to th is foilu... to dnte... Action s to !Jc taken by the Cu sto m er/User: 1... Inform individuals within yo ur organization who need to be aware of this device recall... 2... Check a ll stock areas, ope rating rooms and/or operating room sto ra ge to determine if any devices from the affected product list a re a t your fucility... esponse is required hy May 31 , 2019... f you recei ved the affected parr number (0240 -099-1 55)... our loca l Sn·yker Endoscopy Sales Rep resenta tive w il l he in co ntact to deter mine if you are a ffected by this recall... 3... Please for ward a copy of tl1 is letter to a ny other pe rsonn el with in your facility that you dee m approp riate... e :i ppreci:it e you r cooperation ;ind we recognize the inconveni PnCP thi~ m;iy c:m~e your facility... h::mk you for yo u1· support on this impo rtant matter... lease sen d a ny q uestions to emlorecall@Jstrykcr... m... Sincerely, Vale rie Esn·ada Assnc... egulatory Com11lia11cc Mmiager Stryker f:... 1doscopy The us Food and DrugAd 111ini s m1cion has been no tified of th is action... dverse re;ictions or qual ity p roble ms experienced with the use of this p roduct m ay be r eporte?d to t he r:DA's McdWatch Adverse Even t Repo r ting program either online, by regul;ir m oi l 01· by fox... Page 1 of l STRYKER CONFIDENT IAL -THIS DOCU ME NT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION T HAT IS THE PROPERTY Of STRYKER CORPORATION... EITH£R THIS DOCUMtNT NOR TH E IN~ORMATION HEREIN MAY BE REPRODUCED, USED, DR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION...
File Type: PDF
File Size: 156KB
File Name: connected_or_cart_urgent_medical_device_recall_apri.pdf
Available for download