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

Class 2 Device Recall UBiTIR300 Infrared Spectrophotometer

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


New Search Back to Search Results
 Class 2 Recall
UBiTIR300 Infrared Spectrophotometer
see related information
Date Posted September 01, 2008
Recall Status1 Open
Recall Number Z-1749-2008
Recall Event ID 47536
Premarket Notification
510(K) Number
K013371 
Product Classification Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
Product UBiT®-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.
Code Information 300292 300427 300129 300159 300502 300055 300378 300586 300262 300326 300219 300239 300356 300339 300318 300439 300511 300547 300294 300672 300697 300699 300460 300633 300004 300519 300531 300344 300525 300596 300597 300644 300303 300662 300208 300606 300389 300381 300281 300594 300247 300061 300534 300627 300438 300501 300599 300602 300616 300646 300566 300443 300541 300176 300283 300409 300050 300065 300072 300105 300099 300086 300182 300375 300342 300423 300428 300429 300454 300456 300479 300503 300543 300601 300588 300071 300276 300031 300217 300178 300703 300175 300025 300563 300059 300168 300437 300017 300641 300416 300570 300348 300268 300467 300325 300202 300684 300266 300497 300114 300398 300155 300560 300637 300676 300073 300704 300705 300698 300204 300696 300316 300604 300665 300367 300695 300211 300232 300581 300611 300457 300308 300229 300490 300227 300162 300180 300286 300371 300504 300651 300515 300079 300317 300512 300170 300104 300106 300571 300465 300625 300666 300068 300088 300293 300003 300327 300430 300028 300070 300022 300011 300592 300530 300090 300132 300681 300372 300257 300148 300164 300192 300273 300297 300359 300481 300518 300285 300678 300223 300447 300385 300100 300545 300265 300365 300319 300382 300558 300289 300081 300638 300579 300120 300506 300655 300027 300468 300037 300002 300542 300131 300514 300436 300500 300110 300084 300145 300141 300307 300230 300331 300082 300115 300540 300632 300476 300631 300380 300048 300045 300167 300284 300374 300393 300421 300441 300451 300006 300173 300305 300144 300657 300420 300445 300634 300483 300347 300111 300238 300156 300653 300161 300498 300546 300459 300603 300058 300677 300101 300242 300691 300660 300431 300220 300433 300237 300405 300522 300189 300379 300109 300188 300218 300251 300391 300508 300656 300264 300639 300707 300685 300716 300158 300412 300138 300089 300121 300244 300551 300046 300263 300693 300370 300153 300493 300345 300619 300116 300195 300163 300418 300146 300562 300181 300198 300174 300240 300333 300613 300313 300051 300557 300669 300670 300295 300673 300113 300614 300246 300635 300568 300190 300710 300302 300213 300322 300361 300595 300309 300186 300026 300408 300667 300572 300555 300536 300054 300341 300362 300593 300455 300569 300346 300394 300260 300640 300659 300464 300582 300446 300112 300624 300323 300205 300160 300658 300005 300179 300528 300654 300462 300224 300349 300415 300626 300014 300469 300486 300553 300565 300016 300314 300452 300407 300123 300396 300152 300623 300494 300527 300664 300561 300142 300717 300706 300709 300564 300649 300585 300269 300127 300133 300009 300234 300321 300255 300397 300406 300417 300400 300529 300267 300587 300366 300600 300335 300612 300067 300643 300008 300136 300605 300711 300499 300384 300475 300584 300256 300607 300216 300085 300183 300134 300143 300474 300392 300310 300278 300130 300628 300093 300575 300097 300609 300424 300444 300702 300701 300708 300117 300047 300215 300470 300690 300556 300466 300567 300387 300154 300007 300682 300687 300353 300184 300434 300689 300012 300686 300035 300700 300013 300191 300029 300549 300340 300091 300448 300487 300226 300139 300636 300610 300271 300228 300312 300249 300137 300092 300080 300185 300020 300668 300022 300143 300302 300417 300486 300500 300658 300665 300012 300013 300031 300058 300090 300117 300136 300148 300155 300162 300163 300164 300183 300184 300217 300240 300297 300356 300391 300457 300464 300476 300502 300518 300547 300564 300569 300575 300588 300600 300602 300609 300624 300625 300628 300638 300649 300664 300670 300687 300689 300690 300696 300700 300701 300716
Recalling Firm/
Manufacturer
Otsuka America Pharmaceutical, Inc.
2440 Research Blvd
Rockville, Maryland 20850-3238
For Additional Information Contact OAPI-Meretek
888-637-3835
Manufacturer Reason
for Recall
Medical device power supply may overheat and cause smoke to be emitted from the device.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The initial distributor in the US notified consignees 03/14/08 and 03/26/08 by letter. Consignees were provided two different letters depending on the hours of use of the spectrophotometer. The notifications advised of the firm's preventive service and upgrade program for the instrument's power supply, in which consignees would receive a temporary replacement instrument while the service is completed. Consignees with spectrophotometers having <15000 light source hours were notified similarly, and were provided filters and instructions for cleaning and replacing the filters to protect the power supply from unnecessary accumulation of debris. Contact firm at 1-888-MERETEK for assistance.
Quantity in Commerce 517 units
Distribution The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJQ and Original Applicant = OTSUKA PHARMACEUTICAL CO., LTD.
-
-