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U.S. Department of Health and Human Services

Class 2 Device Recall Access Cardiosystems

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  Class 2 Device Recall Access Cardiosystems see related information
Date Initiated by Firm December 19, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 13, 2004
Recall Number Z-0356-04
Recall Event ID 27992
510(K)Number K020984  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Access AED and Access ALS Automated External Defibrillators
Model No. : 9100-0100
Code Information Serial Numbers: 77067 77341 77374 77401 77427 77468 77068 77344 77375 77402 77428 77469 77215 77351 77376 77403 77429 77470 77217 77352 77377 77404 77430 77471 77287 77353 77378 77405 77432 77472 77288 77354 77379 77406 77433 77473 77295 77355 77380 77407 77434 77474 77296 77356 77381 77408 77435 77475 77297 77357 77382 77409 77436 77476 77302 77358 77383 77410 77437 77477 77303 77359 77384 77411 77438 77479 77304 77360 77385 77412 77439 77480 77305 77361 77386 77413 77440 77481 77306 77362 77387 77414 77441 77483 77307 77363 77388 77415 77442 77484 77308 77364 77389 77416 77443 77485 77309 77365 77390 77417 77444 77651 77319 77366 77391 77418 77445 79335 77320 77367 77392 77420 77446  77321 77368 77394 77421 77447  77334 77369 77396 77422 77448  77336 77370 77397 77423 77462  77337 77371 77398 77424 77463  77338 77372 77399 77425 77464  77339 77373 77400 77426 77465   
Recalling Firm/
Manufacturer		 Access CardioSystems
150 Baker Avenue Ext
Concord MA 01742-2126
For Additional Information Contact Keith Proctor
978-371-4985
Manufacturer Reason
for Recall		 Difibrillator may fail to operate due to a faulty component on the circuit board
FDA Determined
Cause 2		 Other
Action Access CardioSystems notified Distributors by telephone and email on 12/18/03 and 12/19/03. Recall letters were dated 12/19/03 and issued by US Mail. Distributors are requested to locate and return AED's .
Quantity in Commerce 143 units
Distribution AL, CA, LA, FL, OR, NC,TN,. Foreign: Grenada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MKJ and Original Applicant = ACCESS CARDIOSYSTEMS, INC.
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