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Type of Action:
Correction
Stryker Reference:
RA2009-124
Product Description:
Product reference:
Dear Customer
Our manufacturer, Stryker Endoscopy, has notified us of a Product Field Action concerning
the Medical Devices referenced above. Our records indicate that your organisation has been
supplied with some of the subject devices. We would request therefore that you read this
notice carefully and follow the instructions provided by the manufacturer.
We would like to reassure you that only the devices listed are affected by this action.
Description of the problem:
The SDC HD picture/video device will not be able to assign the correct time/date stamp for
saved files after 31 December 2009. On 1 Jan 2010, the system date for all SDC HD units
will re-start from 1 Oct 2001 and begin incrementing from that point onwards.
Potential Hazards associated with use of device
1. SDC system has incorrect date after 1 Jan 2010
2. New cases archived after 1 Jan 2010 using the SDC system have incorrect date
stamps.
Immediate Actions:
1.
Immediately locate all subject devices within your organisation.
2.
Circulate this notification to all interested/affected parties and maintain awareness of
this notice internally until all required actions have been completed within your
organisation.
3.
Immediately inform Stryker of any adverse events concerning use/attempted use of
subject devices.
4.
Inform Stryker if any of the subject devices have been distributed to other
organisations. Please provide contact details so that Stryker can inform the recipients
appropriately.
5.
Complete and sign the attached customer response form on page 3.
(Please complete this form even if you do not have any affected product. This will
preclude the need for Stryker to send any reminder notices.)
6.
Return the completed form, contact details given below:
On receipt of the completed customer response form you will be contacted by a Stryker
representative who will arrange for a Stryker engineer to visit your organisation to
upgrade the affected device(s).
On behalf of Stryker I would like to thank you sincerely for your cooperation in this matter.
Should you require any further information or have any queries on the matter please do not
hesitate to contact the undersigned on XXXXX
Yours faithfully,
RA 2009-124
Description:
SDC HD
Product Reference:
0240050888
Lot Reference:
All
PRODUCT REFERENCE
LOT/SERIAL REFERENCE
Please sign and return this form to acknowledge receipt of product notice.
Name of Hospital/
Address
Organisation
Contact Name
Contact Title
Contact Signature
Contact Phone No.
Date
Ensure that a back-up is taken of the hard drive prior to installation of the
new software.
That a test is performed after installation to ensure that the unit performs as
intended.
We would like to reassure you that, pending completion of the software upgrade, there are no
issues with continuing to use these devices up until the 31 December 2009. However we
request that you read the following instructions carefully and then complete the attached
customer response form to acknowledge.
Requirements:
a. SDCHD
b. Powercord
c. SDCHDdonglesoftwarefix
SDCHDrestoreCD
Instructions:
1. DisconnectallcablesfromtheSDCHDexceptthepowercord.
2. PowerontheSDCHD.
3. SelectCONFIGtocheckwhichsoftwareversionisinstalled.
Ifversion3.0.2.3isinstalledonyourunit,pleaseusetheSDCHDdonglesoftwarefix.
Forallotherversions,pleaseusetheSDCHDrestoreCD.
Ifversion3.0.2.3isinstalled:
LoadtheSDCHDdongleintotheUSBportoftheSDCHD.
1. 1.
LoadtheSDCHDdongleintotheUSBportoftheSDCHD.
2.SelectSAVE
buttonand
Installationwill
start.
3.Installationwill
proceedautomatically
YoumayseeerrormessageG:\Setup.sgncontainsaninvalidpath.
YoumayseeerrormessageG:\Setup.sgncontainsaninvalidpath.
Ifyouseethefollowingmessage,theusermayclickokordisregard.
Ifyouseethefollowingmessage,theusermayclickokordisregard.
Installationwillproceedautomatically.
4.SelectNEXTon
prompts.
5.Systemwill
reboot
automatically.
IfanyotherSDCHDsoftwareversionisinstalled(anyversionotherthan3.0):
1. InserttheSDCHDrestoreCDintotheCDROMdrive.
2. Installationwillproceedautomatically.
3. Systemwillrebootautomatically.