FDA Medical Device Recalls (openFDA)
Cardiac Science, Inc.: Power Heart AED Automatic External Defibrillator, Model 9200 RD
- Recall number
- Z-1033-04
- Recalling firm
- Cardiac Science, Inc.
- Product
- Power Heart AED Automatic External Defibrillator, Model 9200 RD
- Status
- Terminated
- Initiated
- 2004-05-24
- Posted
- 2004-07-20
- Terminated
- 2005-11-18
- Reason
- Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
- Root cause
- Other
- Action
- A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.
- Quantity
- not on file
- Distribution
- The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
- Lot, serial or model codes
- Serial Numbers of the recalled Model 9200 RD and Model 9210 RD AEDs are: 300122, 300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426, 306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through 308530, 308839, 309180, 309218, 309236, 309426, 309438, 309561, 309691 through 309894, 309897, 309903 through 309908, 309913, 309915, 309917, 309922, 309924, 309929, 309930, 309944, 309959, 309971 through 310170, 310181, 310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through 312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973, 317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278, 318171 ¿ 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435, 318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043
- 510(k) numbers
- ["K011901"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 2112020
- Firm city
- Minneapolis
- Firm state
- MN
- 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