Class 2 Device Recall Zoll E Series Defibrillator with 12 Lead ECG

• Date Initiated by Firm: January 15, 2008
• Date Posted: June 28, 2008
• Recall Status: Terminated on February 06, 2017
• Recall Number: Z-1167-2008
• Recall Event ID: 46408
• 510(K)Number: K042007
• Product Classification: Automated external defibrillator - Product Code MKJ
• Product: Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.
• Code Information: Serial Numbers: AB05D000031 AB05D000034 AB05F000276 AB05F000277 AB05F000278 AB05F000279 AB05F000280 AB05F000281 AB05F000282 AB05F000283 AB05F000284 AB05F000286 AB05F000287 AB05F000288 AB05F000289 AB05F000290 AB05F000291 AB05F000292 AB05F000293 AB05F000294 AB05F000295 AB05F000296 AB05F000297 AB05F000298 AB05F000299 AB05F000300 AB05F000301 AB05F000302 AB05F000303 AB05F000304 AB05F000305 AB05F000306 AB05F000307 AB05F000308 AB05F000309 AB05F000310 AB05F000311 AB05F000312 AB05F000313 AB05F000314 AB05F000315 AB05F000316 AB05F000317 AB05F000318 AB05F000319 AB05F000320 AB05F000321 AB05F000322 AB05F000323 AB05F000324 AB05F000325 AB05F000326 AB05F000327 AB05F000328 AB05F000329 AB05F000330 AB05F000331 AB05F000332 AB05F000333 AB05F000334 AB05F000335 AB05F000336 AB05F000337 AB05F000338 AB05F000339 AB05F000340 AB05F000341 AB05F000342 AB05F000343 AB05F000344 AB05F000345 AB05F000346 AB05F000347 AB05F000348 AB05F000349 AB05F000350 AB05F000351 AB05F000352 AB05F000353 AB05F000354 AB05F000355 AB05F000356 AB05F000357 AB05F000358 AB05F000359 AB05F000360 AB05F000361 AB05F000362 AB05F000363 AB05F000364 AB05F000365 AB05F000366 AB05F000367 AB05F000368 AB05F000369 AB05F000370 AB05F000371 AB05F000372 AB05F000373 AB05F000374 AB05F000375 AB05F000376 AB05F000377 AB05F000378 AB05F000379 AB05F000380 AB05F000381 AB05F000382 AB05F000384 AB05F000385 AB05F000386 AB05F000387 AB05F000388 AB05F000389 AB05F000390 AB05F000391 AB05F000392 AB05F000393 AB05F000395 AB05F000396 AB05F000397 AB05F000398 AB05F000399 AB05F000401 AB05F000402 AB05F000403 AB05F000404 AB05F000405 AB05F000406 AB05F000407 AB05F000408 AB05F000409 AB05F000411 AB05F000412 AB05F000413 AB05F000414 AB05F000415 AB05F000416 AB05F000417 AB05F000419 AB05F000420 AB05F000421 AB05F000422 AB05F000423 AB05F000424 AB05F000425 AB05F000426 AB05F000427 AB05F000429 AB05F000430 AB05F000431 AB05F000432 AB05F000433 AB05F000434 AB05F000436 AB05F000437 AB05F000438 AB05F000439 AB05F000440 AB05F000441 AB05F000442 AB05F000443 AB05F000444 AB05F000445 AB05F000446 AB05F000447 AB05F000448 AB05F000449 AB05F000450 AB05F000451 AB05F000452 AB05F000453 AB05F000454 AB05F000455 AB05F000456 AB05F000457 AB05F000458 AB05F000459 AB05F000460 AB05F000461 AB05F000462 AB05F000463 AB05F000464 AB05F000465 AB05F000466 AB05F000467 AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000472 AB05F000473 AB05F000474 AB05F000475 AB05F000476 AB05F000477 AB05F000478 AB05F000479 AB05F000480 AB05F000481 AB05F000482 AB05F000483 AB05F000484 AB05F000485 AB05F000486 AB05F000487 AB05F000488 AB05F000489 AB05F000491 AB05F000492 AB05F000493 AB05F000494 AB05F000495 AB05F000496 AB05F000497 AB05F000498 AB05F000499 AB05F000500 AB05F000501 AB05F000502 AB05F000503 AB05F000504 AB05F000505 AB05F000506 AB05F000508 AB05F000511 AB05F000512 AB05F000513 AB05F000514 AB05F000515 AB05F000579 AB05H000516 AB05H000517 AB05H000518 AB05H000519 AB05H000520 AB05H000521 AB05H000522 AB05H000523 AB05H000524 AB05H000525 AB05H000526 AB05H000527 AB05H000528 AB05H000529 AB05H000530 AB05H000531 AB05H000532 AB05H000533 AB05H000534 AB05H000535 AB05H000536 AB05H000537 AB05H000538 AB05H000539 AB05H000540 AB05H000541 AB05H000542 AB05H000543 AB05H000544 AB05H000545 AB05H000546 AB05H000547 AB05H000548 AB05H000549 AB05H000550 AB05H000551 AB05H000552 AB05H000553 AB05H000554 AB05H000555 AB05H000556 AB05H000557 AB05H000558 AB05H000559 AB05H000560 AB05H000561 AB05H000562 AB05H000563 AB05H000564 AB05H000565 AB05I000566 AB05I000567 AB05I000568 AB05I000569 AB05I000570 AB05I000571 AB05I000572 AB05I000574 AB05I000575 AB05I000576 AB05I000577 AB05I000578 AB05I000579 AB05I000580 AB05I000581 AB05I000582 AB05I000583 AB05I000584 AB05I000585 AB05I000586 AB05I000587 AB05I000588 AB05I000589 AB05I000590 AB05I000591 AB05I000592 AB05I000593 AB05I000594 AB05I000595 AB05I000596 AB05I000597 AB05I000598 AB05I000599 AB05I000601 AB05I000602 AB05I000603 AB05I000604 AB05I000605 AB05I000606 AB05I000607 AB05I000608 AB05I000609. 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• Recalling Firm/ Manufacturer: ZOLL Medical Corporation, World Wide Headquarters; 269 Mill Rd; Chelmsford MA 01824-4105
• For Additional Information Contact: 978-421-9655 Ext. 413
• Manufacturer Reason for Recall: Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.
• FDA Determined Cause: Software design
• Action: Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011.
• Quantity in Commerce: 5,018 units
• Distribution: Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA.
• 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 = ZOLL MEDICAL CORP.