FDA Medical Device Recalls (openFDA)
Zoll Circulation, Inc.: Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
- Recall number
- Z-2090-2014
- Recalling firm
- Zoll Circulation, Inc.
- Product
- Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
- Status
- Terminated
- Initiated
- 2013-07-16
- Posted
- 2014-07-22
- Terminated
- 2014-07-22
- Reason
- Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
- Root cause
- Labeling Change Control
- Action
- Zoll Japan handled the recall.
- Quantity
- 161 Nickel Metal batteries, 40 LifeBand
- Distribution
- Distributed in Japan.
- Lot, serial or model codes
- LifeBand Single Pack: product code 8700-03, lot 41515; Nickel-Metal hyride battery: product code 8700-0702-03: serial numbers: 03690,03695,03696,03700,03701,03702,03706,03707,03708,03709,03710, 03711,03715,03717,03718,03720,03721,03726,03727,03728,03730,03732, 03733,03734,03736,03738,03742,03743,03745,03749,03750,03758,03768, 03770,03772,03773,03778,03779,03781,03782,03783,03786,03788,03797, 03799,03805,03806,03809,03863,03866,03867,03869,03871,03874,03875, 03880,03881,03882,03883,03888,03889,03890,03893,03894,03895,03896, 03899,03901,03906,03910,03916,03926,03943,04064,04067,04100,04119, 04133,04193,04223,04233,04301,04303,04304,04337,04364,04397,04399, 04400,04405,04406,04408,04409,04410,04411,04415,04417,04418,04419, 04420,04421,04422,04423,04433,04442,04468,04470,04478,04482,04483, 04510,04511,04514,04585,04586,04587,04588,04589,04591,04593,04594, 04595,04596,04598,04599,04600,04603,04607,04608,04610,04611,04612, 04617,04619,04635,04641,04662,04674,04675,04676,04678,04679,04682, 04704,04705,04712,04718,04744,04762,04763,04773,04774,04777,04780, 04782,04785,04786,04789,04795,04828,04838.
- 510(k) numbers
- ["K011046","K022345","K032852","K040453"]
- PMA numbers
- not on file
- Product code
- DRM
- Firm FEI
- 3003793491
- Firm city
- San Jose
- Firm state
- CA
- 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