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Association of Indian Medical Device Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
Dentsply Tulsa Dental Specialties, Trading as Dentsply
Endodontics - ProTaper Universal Gutta Percha
The assortment packs of ProTaper Universal Gutta Percha
points, item# PTUGPAST with lot# 110381, may have the size F1 in the F5 slot and
the size F5 in the F1 slot.
GE Hangwei Medical Systems Co. Ltd. - Optima MR360 1.5T
Optima MR360 1.5T: in the event of a significant power surge,
such as one that might be caused by a lightning strike or a utility equipment
failure, there is a possibility that the fuse in the MRU could be affected. This
situation could indirectly lead to a potential hazard if an emergency magnet
quench is required.
GE Medical Systems LLC - Signa HDX MR System; Discovery
MR750 MR System; Discover MR450 1.5T MR System
In the event of a significant power surge, such as one that
might be caused by a lightning strike or a utility equipment failure, there is a
possibility that the fuse in the MRU (magnet rundown unit) circuit could be
affected. This situation could indirectly lead to a potential hazard if an
emergency magnet quench is required.
Hologic, Inc. - Biopsy Site Identification Markers;
Hologic Breast Biopsy Kit
This recall is being performed due to the fact that the
product is not licensed by Hologic in Canada. The product is not defective in
any way.
Instumentation Laboratory Company - GEM Premier 4000
System
Rare occurrences of falsely lowered K+ results (potential
negative bias of 0.6 to 1.2 mmol/l) can occur during cartridge life on patient
blood analysis, leading to erroneous results with potentially severe impact to
patient treatment.
Invivo Corporation - Expression MRI Patient Montoring
System-Main Unit
During transport of the cart with a docked DCU, a front
caster (wheel) may become loose and fall off. If this occurs, the cart will
become unbalanced and fall.
Linvatec Corporation D.B.A. ConMed Linvatec - Xenon
Universal Light Source
ConMed Linvatec has been advised by a supplier that the power
supply in the manufacture of the lS7600 and lS7700 potentially has an unapproved
component and may not meet finished product requirements.
Medacta International SA - Versafitcup Double Mobility
Liner Inserter
One part of the instrument was made with wrong raw material,
common steel instead of stainless steel. A mistake by the raw material supplier
that sent to Medacta's supplier, a certificate for the stainless steel but with
the wrong material. The supplier did not notice the mistake and manufactured the
entire lot. The wrong material was discovered to be used.
Nobel Biocare AB - Impression Coping Open Tray CC NP 5 x
14mm
Nobel Biocare has received complaints regarding an incorrect
impression coping. After investigation at Nobel Biocare Karlskoga it was
discovered that the wrong label and color coding has been used for one batch of
the product impression coping open tray CC. The information stated on the label
is: Impression Coping Open Tray CC NP 5 x 14 mm (article no. 36261. Lot 742552).
The impression coping included in this package is impression coping open tray cc
rp 6 x 14 mm (article no. 36266).
Philips Medical Systems - SureSigns VS3
Speakers on SureSigns patient monitors and vital signs
monitors may fail prematurely. This failure may be identified by the display of
a "speaker malfunc" message in the alarm message area or an "audio failed"
message in the main screen of the device or by the absence of audible sound.
Philips Medical Systems (Cleveland), Inc. - Brightview
Gamma Camera System with 3/8" Crystal
There is a gap between the stationary portion of the table
and the extendable patient pallet. When the pallet is being translated patients'
body parts (e.g. hair, skin, or fingers) or items (such as clothes and IV
tubing) may get caught between the stationary portion of the table and
extendable patient pallet if the instructions for use are not followed.
Siemens AG - Coherence Therapist
Sites with at least Primeview (R2.1 or 2.2) and RTT 4.1
connected to the same Lantis DB (version 6.1 and 8.3) may observe concurrent DB
access issues. In this case Primeview displays an error message that informs the
user about potential recording failures. A segment recording failure with data
loss might be the consequence.
Siemens AG - Artiste MV - Linear Accelerator - Syngo RT
Therapist Assisit; Artiste MV - Linear Accelerator - Syngo RT Therapist
There is a potential safety risk when delivering beams
without imaging segments for which a manual pause for the imaging segment is
set. As a consequence of this risk the patient may be injured or mistreated.
Siemens AG - Luminos DRF Updated recall # 63437 previously
posted on 2011-05-30.
This update instruction provides multiple bug fixes and
system improvements, such as, enhanced direct radiation detection leading to
wrong window values, wrong PEX-settings for spatial frequency parameters leading
to black images, imaging system crash with cancel of reject analysis window,
wrong flags in patient list, improvement of auto delete function, improvement of
error 3070/032, and improvement of error 7031/032.
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