FDA Medical Device Recalls (openFDA)
Cambridge Heart, Inc.: The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
- Recall number
- Z-1776-2010
- Recalling firm
- Cambridge Heart, Inc.
- Product
- The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
- Status
- Terminated
- Initiated
- 2010-04-29
- Posted
- 2010-06-07
- Terminated
- 2011-09-20
- Reason
- Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.
- Root cause
- Process control
- Action
- The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.
- Quantity
- 2740
- Distribution
- Nationwide
- Lot, serial or model codes
- Alternans Sensor Kits Kit Dispenser Box Lot # 550312 Lot # 5229 Lot # 700104 Lot # 5734 Lot # 700362 Lot # 6343 Lot # 700383 Lot # 6433 Lot # 700585 Lot # 6853 Lot # 700589 Lot# 6966 Lot # 700649 Lot # 7178
- 510(k) numbers
- ["K002230"]
- PMA numbers
- not on file
- Product code
- DRX
- Firm FEI
- 3000215432
- Firm city
- Tewksbury
- 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