FDA Medical Device Recalls (openFDA)
Access CardioSystems: Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
- Recall number
- Z-0356-04
- Recalling firm
- Access CardioSystems
- Product
- Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
- Status
- Terminated
- Initiated
- 2003-12-19
- Posted
- 2004-07-20
- Terminated
- 2004-07-13
- Reason
- Difibrillator may fail to operate due to a faulty component on the circuit board
- Root cause
- 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
- 143 units
- Distribution
- AL, CA, LA, FL, OR, NC,TN,. Foreign: Grenada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K020984"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3003585458
- Firm city
- Concord
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28