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AED Recalls
| Alert Details for #2006070222 (Released 07/14/2006 17:41 EDT) |
| Description: |
Update to RASMAS alert 2006070091 of 7/7/06 (Part Numbers Specified) Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator |
| Manufacturer: |
MRL Inc., A Welch Allyn Company, Buffalo Grove, IL |
| Reason: |
The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. |
| Analyst Comments: |
Confirm receipt of manufacturer's notice dated June 30, 2006. If this product is in your inventory, please contact the manufacturer, distributor, or your service representative for additional information. MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction. For additional information, contact Jamie Arnold 315-685-4599 or Welch Allyn: (800) 462-0777 or (847) 520-0300 or www.welchallyn.com |
| Alert Type: |
Recall URGENT |
Source Alert Type: |
FDA Recall Class I |
| Domain: |
Biomedical Devices |
Source Type: |
Food and Drug Administration |
| Distribution: |
Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus,
France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon,
Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa,
Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United
Kingdom and Vietnam. |
Source Date: |
07/14/2006 |
| Product Description |
Model/Product Number |
Stock Identifiers |
Volume |
Recall ID |
| Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator |
PIC 50 |
Part numbers 971081 , 971082 , 971083 and 971084; serial numbers 80104 ,
80119 , 80120 , 80204 , 80211 , 80212 , 80429 , 80432 , 80569 , 80627 ,
80661 , 80685 , 80880 , 80964 , 81056 , 81134 , 81263 , 81293/81295 ,
81303 , 81445/ 81448 , 81733 , 81738 , 81739 , 81744/81752 , 81757 ,
81761/81781 , 81802/81807 , 81824 , 81825 , 81835 , 81845 , 81846 , 81852
, 81864 , 81865 , 81868 , 81869 , 81884/81886 , 81892/81897 , 81918/81955
, 81957 , 81983/81990 , 81996/82025 , 82027/82033 , 82035/82039 , 82043 ,
82044 , 82061/82080 , 82084 , 82097/82111 , 82122/82128 , 82133 ,
82136/82143 , 82150/82169 , 82172/82204 , 82245 , 82252/82273 , 82283/82286
, 82307/82330 , 82340/82349 , 82405/82426 , 82430 , 82460/82490 ,
82498/82553 , 82555/82565 , 82568/82570 , 82612/82631 , 82654/82673 , 82689
, 82690 , 82773/82813 , 82827/82830 , 82852 , 82856/82859 , 82906 , 82936
, 82937 , 82958/82977 , 82983/83013 , 83060/83071 , 83083/83090 , 83093 ,
83142/83147 , 83153/83172 , 83198/83239 , 83255 , 83368/83370 , 83400/83407
, 83414/83418 , 83420/83429 , 83440/83443 , 83499/83517 , 83578/83580 ,
83633 , 83644 , 83645 , 83654 , 85001/85005 , 85009/85013 , 85026/85029 ,
85032/85052 , 85073/85079 , 85093 , 85094 , 85110 , 85111 , 85143/85157 ,
85187/85201 , 85223 , 85224 , 85226/85238 , 85244/85249 , 85329 ,
85332/85334 , 85337/85350 , 85364 , 85365 , 85368/85370 , 85381 ,
85388/85398 , 85402/85404 , 85410/85414 , 85420/85433 , 85441 , 85505/85515
, 85517/85520 , 85522/85530 , 85534 , 85552 , 85554/85557 , 85587/85589 ,
85602/85607 , 85619/85623 , 85630 , 85645/85655 , 85658/85667 , 85686 ,
85728/85734 , 85755/85757 , 85761/85766 , 85771/85785 , 85787/85793 , 85810
, 85812/85823 , 85825/85838 , 85856/85872 , 85877/85884 , 85888/85902 ,
85931/85933 , 85945 , 85955 , 85964 , 85967/85970 , 86017 , 86018 ,
86024/86029 , 86055/86057 , 86103 , 86104 , 86118 , 86141/86147 , 86149 ,
86150 , 86222/86228 , 86230 , 86245 , 86256/86258 , 86261/86268 ,
86281/86283 , 86289/86293 , 86295 , 86296 , 86299 , 86305 , 86306 , 86314
, 86315 , 86320/86322 , 86324/86328 , 86334 , 86335 , 86358 , 86359 ,
86385 , 86387 , 86389/86399 , 86400 , 86411 , 86412 , 86419 , 86420 ,
86439 , 86440. |
673 units - USA, 511 units - International total. |
Z-1195-06 |
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