• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PCR Compano Basic Reader using 100127V as mains voltage

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PCR Compano Basic Reader using 100127V as mains voltagesee related information
Date Initiated by FirmAugust 12, 2016
Create DateAugust 29, 2016
Recall Status1 Terminated 3 on July 15, 2020
Recall NumberZ-2681-2016
Recall Event ID 74920
510(K)NumberK964124 
Product Classification System, image processing, radiological - Product Code LLZ
ProductPCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Code Information Serial Numbers: 2704471 2704473 16620843 16620844 16620845 16720992 16721001 17121932 26523285 26523287 26523292 26824120 26924172 26924179 27024418 27124646 27124650 27224878 27225020 36125096 36225366 36225367 36225370 36225371 36225372 36225373 36225429 36225431 36225432 36225437 36225438 36325634 36325635 36325639 36325641 36325805 36325810 36325811 36325812 36325813 36325814 36325819 36325820 36425835 36425837 36425838 36425839 36425842 36526123 36526129 36526134 36526135 36526138 36526139 36526140 36526141 36526142 36526144 36526201 36526202 36526206 36526211 36526212 36526213 36626333 36726559 36726560 36726562 36826721 36826722 36826726 36826728 36926990 36926991 37127470 37127472 37127473 46127902 46127903 46127905 46127906 46127909 46127910 46127911 46127912 46127913 46127914 46127992 46127994 46127997 46128000 46128001 46128003 46128004 46128008 46128009 46128010 46128011 46228209 46228211 46228215 46228216 46228228 46228229 46328495 46328496 46328498 46328502 46328529 46328546 46328547 46328548 46358530 46428796 46428799 46428802 46428803 46428804 46428805 46428807 46428815 46428816 46529074 46529085 46629338 46629344 46629346 46629352 46629355 46629356 46629357 46629359 46629360 46629363 46729628 46729629 46729631 46729632 46729633 46729634 46729635 46729636 46729637 46729639 46729640 46729644 46729723 46729725 46729726 46829974 46829975 46829976 46829978 46829980 46829981 46829982 46829983 46829984 46829985 46829992 46829993 46829994 46829995 46829996 46930348 46930350 46930351 46930352 46930354 46930521 46930523 46930524 46930525 46930528 46930529 47030712 47030713 47030714 47030715 47030716 47030719 47030721 47030723 47030724 47030725 47030726 47131062 47131069 47131070 47131071 47131072 47131073 47131074 47131075 47231476 47231481 56232069 56232070 56232089 56232090 56232091 56332428 56332430 56332433 56332437 56332438 56332449 56332451 56332453 56432826 56432840 56432841 56432843 56432845 56432852 56533223 56533224 56533225 56533226 56533227 56533234 56533236 56533238 56633622 56633623 56633624 56633625 56633626 56633627 56734212 56734213 56734215 56734217 56734224 56834641 56834644 56834646 56834647 56834650 56834651 56834652 56834653 56834656 56834657 56834659 57135359 57135362 57135416 57135417 57135420 57135421 57135422 57135423 57135424 57135425 57135427 57135428 57135429 57135430 66135663 66135668 66135670 66135671 66135672 66235900 66235901 66235903 66235906 66436199 66436200 66436203 66436204 66436207 66436212 66536270 66536272 66536273 SN26924173 SN47030727 26523286 26723780 26723781 2672378226422949 27124649 27124651 27124652 27124653 27224871 27224872 27224875 36726561 36826727 46529069 46529073 46529076 46529078 46529083 46529084 56131759 56232072 56232073 56232074 56232076 56232077 56232078 56332434 56332436 56734214 56734216 57135355 57135357 57135358 57135363 57135364 57135365 57135366 57135367 66235899 66536244 27224873 27224874 36626334 36726553 46428806 46428817 46529077 46529082 46629339 46829977 46829979 56332435 56432829 56432830 66436206 16620838 16620840 16721003 16721005 16921351 26422953 26824118 27024470 27225013 36125097 36125098 36125301 36125304 36125305 36526126 37127471 46228222 46228223 46228224 46629341 46629342 46629343 46629364 47030718 47131067 47231483 47231484 47231485 56131753 56131755 56131756 56232079 56232094 56332431 56332439 56332440 56332443 56332445 56332447 56432823 56432846 57135301 57135303 57135352 57135353 57135354 66436185 66436222, and SN36125302. 
Recalling Firm/
Manufacturer
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
FDA Determined
Cause 2
Component design/selection
ActionPhilips will send a Field Safety Notice to all affected customers on August 12, 2016. The notice informs consignees of the issue and informs them that Philips will replace the power supply unit of the PCR Compano Basic reader system of all affected units free of charge (FCO73200037).
Quantity in Commerce388
DistributionWorldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, TX, VT, WA, WI, WV, and WY; and, the countries of Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
-
-