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MEDRAD® Stellant CT Injection System with Certegra Workstation

by Bayer Medical Care Inc. EUDAMEDGUDID

Active European Union Open recall

Ref SSH 200F

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0082I3T Basic UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258025384 UDI-DIDate22 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-3147-2026 FDA Class II initiated 31 Jul 2026

    Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

    • Terminated Z-0147-2012 FDA Unclassified (pre-2012) initiated 24 Oct 2011

    Packaging may exhibit open seals - sterility compromised

    • Terminated Z-1954-2010 FDA Unclassified (pre-2012) initiated 24 May 2010

    Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.

    • Terminated Z-0154-06 FDA Unclassified (pre-2012) initiated 10 Oct 2005

    the heat maintainer, an accessory, may overheat and deform the disposable syringe

    • Terminated Z-0257-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Sterility can be compromised by a tear in the outer packaging.

    • Terminated Z-0039-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004

    Sterility can be compromised by a component tearing the outer packaging

Specification

EUDAMED · GUDID

Trade Name
MEDRAD® Stellant CT Injection System with Certegra Workstation EUDAMED
MEDRAD® Stellant Heat Maintainer GUDID
MEDRAD® Stellant CT Injection System GUDID
Generic Name
CT contrast medium injection system, line-powered, mobile
Model / Ref / Catalog
SSH 200F
Description
MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
MAINTAIN,SYR HEAT,STEL,FLS2,UDI,BATCH,JA (85864483)
"SSH 200, HEAT MAINTAINER (85276581)"
Primary DI / UDI-DI
00616258025384, 00616258008882, 00616258020662, 00616258027418
Basic UDI-DI
0616258TFCN-0082I3T
510(k) Number
FDA Product Code
DXT
EMDN Code
A030105 Fluids heating systems
GMDN Term
CT contrast medium injection system, line-powered, mobile
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No