FDA Medical Device Recalls (openFDA)
: GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
- Recall number
- Z-0308-03
- Recalling firm
- Product
- GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
- Status
- Open, Classified
- Initiated
- 2002-11-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Extended charge times prior to defibrillation shock.
- Root cause
- not on file
- Action
- An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.
- Quantity
- 2539 devices
- Distribution
- The devices have been distributed nationwide in the United States and worldwide. 2,151 units have been distributed in the United States, and 387 units have been distributed worldwide outside the U.S.
- Lot, serial or model codes
- All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- not on file
- Firm city
- Fridley
- Firm state
- not on file
- 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