FDA Medical Device Recalls (openFDA)
Independence Technology LLC: iBOT 4000 Mobility System Battery pack.
- Recall number
- Z-1775-2010
- Recalling firm
- Independence Technology LLC
- Product
- iBOT 4000 Mobility System Battery pack.
- Status
- Terminated
- Initiated
- 2010-02-22
- Posted
- 2010-06-05
- Terminated
- 2010-10-01
- Reason
- A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.
- Root cause
- Device Design
- Action
- The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.
- Quantity
- 192 devices
- Distribution
- Nationwide and to the United Kingdom.
- Lot, serial or model codes
- Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s) Revision 2.0. Serial number contains the month/year of manufacture followed by a sequential number.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020033"]
- Product code
- IMK
- Firm FEI
- 3003508375
- Firm city
- Warren
- Firm state
- NJ
- 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