Skip to content

X Series 610-2271511-01

by Zoll Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847946099558 UDI-DI Date4 May 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1311-2014 FDA Class II initiated 5 Mar 2014

    Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

    • Terminated Z-2401-2012 FDA Class II initiated 16 Aug 2012

    Shipped with incorrect software

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
X Series
Generic Name
Rechargeable professional automated external defibrillator
Model / Reference
610-2271511-01
Primary DI / UDI-DI
00847946099558
FDA Product Code
MKJ
GMDN Term
Rechargeable professional automated external defibrillator
Device Class
Class III
Regulation Number
870.5310
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Physiologic-monitoring defibrillation system

Cleared under the same submission (K112432)

Show all (12)

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No