FDA Device Recall Z-0014-2009: Intraop Medical Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2009.

Recall Res Number

Z-0014-2009

Recalling Firm / Manufacturer

Intraop Medical Corporation

FEI Number

3001874253

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-06-20

Date Posted

2008-10-03

Date Terminated

2011-04-05

Product Code

LHN

Event Number

49022

Product Quantity

24 units

Product Description Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

Reason for Recall Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.

Action Details Recall initiated on 06/20/2008, advising users via Advisory Notice that a safety upgrade would be available. Two options are given to either self inspect the product or schedule an Intraop Authorized Field Service Engineer to visit their facility to perform the inspection. The letter notes that if no nut failure was evident, the machine could still be used. The firm continues to send retrofit kits.

Distribution Pattern Worldwide Distribution

Code Information / Serial Numbers all units

Related Establishments / Registrations

HITACHI HIGH-TECH CORP., KASHIWANOHA Registration: 1000162206 View Registration
SUN NUCLEAR CORPORATION Registration: 1038814 View Registration
IBA Dosimetry America Registration: 1062572 View Registration
DIACOR, INC. Registration: 1721113 View Registration
OPTIVUS PROTON THERAPY, INC. Registration: 2032229 View Registration
Anholt Technologies Inc. Registration: 2247992 View Registration
Varian Medical Systems, Inc Registration: 2916710 View Registration
INTRAOP MEDICAL CORP. Registration: 2953704 View Registration
ION BEAM APPLICATIONS S.A. Registration: 3000256071 View Registration
HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION Registration: 3003993895 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
MASSACHUSETTS GENERAL HOSPITAL Registration: 3005374502 View Registration
MEDCOM GMBH Registration: 3006579682 View Registration
MEVION MEDICAL SYSTEMS, INC. Registration: 3007087027 View Registration
DYN'R Registration: 3008317830 View Registration
Varian Medical Systems International India Private Ltd Registration: 3009754495 View Registration
Varian Medical Systems Particle Therapy GmbH & Co. KG Registration: 3010658895 View Registration
PRONOVA SOLUTIONS, LLC Registration: 3010726836 View Registration
McLaren Health Care Registration: 3015178562 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
EHMET HEALTH Registration: 3016872563 View Registration
EMPNIA INC. Registration: 3042022819 View Registration
ANZAI MEDICAL CO, LTD. Registration: 8031557 View Registration
BRAINLAB SE Registration: 8043933 View Registration
ORFIT INDUSTRIES NV Registration: 9613183 View Registration
IBA Dosimetry GmbH Registration: 9614952 View Registration
PTW FREIBURG Registration: 9681124 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0014-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer