Ziehm Imaging GmbH | Donaustraße 31 | 90451 Nürnberg | Tel +49 (0)911.21 72-0 | Fax +49 (0)911.21 72-390 | info@ziehm-eu.com | www.ziehm.com Deutsche Bank | BLZ 700 700 10 | Kontonummer 926 056 300 | SWIFT-BIC.: DEUTDEMMXXX | IBAN DE21 7007 0010 0926 0563 00
Postbank | BLZ 860 100 90 | Kontonummer 490 554 900 | SWIFT-BIC.: PBNK DE FF 860 | IBAN DE 63 8601 0090 0490 5549 00 Commerzbank | BLZ 760 800 40 | Kontonummer 229 768 100 | SWIFT-BIC.: COBA DE FF 760 | IBAN DE 12 7608 0040 0229 7681 00
USt-ID-Nr. DE 133 545 793 | Amtsgericht Nürnberg, HRB 5615 | WEEE-Reg. Nr. DE 226 636 19 | Geschäftsführer: Klaus Hörndler, Stephan Dippold Ziehm Imaging GmbH|Donaustrasse 31|90451 Nuremberg
xxxxx
xxxxxxxxxx xxxxxxxxxx xxxxxxx
Urgent Field Safety Notice
29.04.2013 Dear Customer,
Ziehm Imaging has specialized on the development, manufacturing and global distribution of mobile X-ray devices. The safety of our devices for patients and operators in everyday use of our devices is our primary concern.
This field safety notice is issued to inform about corrective actions we have initiated for our devices
Subject: Mobile X-ray C-arms manufactured by Ziehm Imaging GmbH Model: xxxxxx Serial-No: xxxx
Issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device.
To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device.
Normative Background: The international Standard IEC 60601-1 and applicable collateral Standards request, that all energy-powered movements, that may result in patient injuries, have to be equipped with an emergency stopping device
The purpose of the emergency stopping device is to immediately terminate or eliminate a hazardous situation.
Ziehm Imaging GmbH | Donaustraße 31 | 90451 Nürnberg | Tel +49 (0)911.21 72-0 | Fax +49 (0)911.21 72-390 | info@ziehm-eu.com | www.ziehm.com Deutsche Bank | BLZ 700 700 10 | Kontonummer 926 056 300 | SWIFT-BIC.: DEUTDEMMXXX | IBAN DE21 7007 0010 0926 0563 00
Postbank | BLZ 860 100 90 | Kontonummer 490 554 900 | SWIFT-BIC.: PBNK DE FF 860 | IBAN DE 63 8601 0090 0490 5549 00 Commerzbank | BLZ 760 800 40 | Kontonummer 229 768 100 | SWIFT-BIC.: COBA DE FF 760 | IBAN DE 12 7608 0040 0229 7681 00
USt-ID-Nr. DE 133 545 793 | Amtsgericht Nürnberg, HRB 5615 | WEEE-Reg. Nr. DE 226 636 19 | Geschäftsführer: Klaus Hörndler, Stephan Dippold
Potential Hazardous Situation:
When moving the C-arm up and down, the energy-powered vertical movement might lead to a potential hazardous situation (device collides with the patient or operator)
Precautions: All affected devices can be further operated until the correction has been carried out on-site.
In case of an hazardous situation the user can resolve the hazardous situation either by:
• operating the power-of the switch either on the front panel or on the monitor cart
• removing the power cable
• activate the push-buttons for reverse vertical movement and keeping the push-button pressed until no person is any longer in the risk zone or the device stops operating.
Please make all staff members working with the affected device alert, and familiarize them with all possibilities to resolve the hazardous situation
Corrective Actions: Your device will be retrofitted with an emergency stopping device, to restore compliance with applicable standards.
We are going to send you necessary components and information which are suitable to implement the measure efficiently in a timely manner.
Your Competent Authority has been informed about our action.
In case you have any concerns regarding this field safety notice, please apply to our Safety Officer Ralf Vogt
:
FSCA@ziehm-eu.com; Fon: +49 (0) 911.2172. 218; Fax
:
+49 (0)911.2172.39.143Please acknowledge the receipt of this field safety notice by returning the attached Field Safety Notice Acknowledgement Form.
Kind regards
Ralf Vogt Stefan Fiedler
Ziehm Imaging GmbH Ziehm Imaging GmbH
Safety Officer Director Quality Management/Regulatory Affairs
Ziehm Imaging GmbH | Donaustraße 31 | 90451 Nürnberg | Tel +49 (0)911.21 72-0 | Fax +49 (0)911.21 72-390 | info@ziehm-eu.com | www.ziehm.com Deutsche Bank | BLZ 700 700 10 | Kontonummer 926 056 300 | SWIFT-BIC.: DEUTDEMMXXX | IBAN DE21 7007 0010 0926 0563 00
Postbank | BLZ 860 100 90 | Kontonummer 490 554 900 | SWIFT-BIC.: PBNK DE FF 860 | IBAN DE 63 8601 0090 0490 5549 00 Commerzbank | BLZ 760 800 40 | Kontonummer 229 768 100 | SWIFT-BIC.: COBA DE FF 760 | IBAN DE 12 7608 0040 0229 7681 00
USt-ID-Nr. DE 133 545 793 | Amtsgericht Nürnberg, HRB 5615 | WEEE-Reg. Nr. DE 226 636 19 | Geschäftsführer: Klaus Hörndler, Stephan Dippold
*xxxx*
Field Safety Notice Acknowledgement Form
Please return this form to Ziehm Imaging GmbH either via Fax: +49.(0)911.2172-390
scanned via E-Mail: SiBa@ziehm-eu.com
Recipient Information Contact Name
Facility
E-mail Address Centre/Department Adress Line 1 Adress Line 2 City
Zip/Postal Code Country
Subject Device Information
Mobile C-Arms Ziehm Imaging GmbH
Model: Serial-No.:
I hereby confirm the acknowledgement of the Field Safety Notice, issued by Ziehm Imaging GmbH on the 29th of April 2013
☐ I’m the user of the a.m. device. I have read the remarks of the Field Safety Notice concerning the safety of the subject devices as well as proposed precautions.
☐ I’ not the user of the a.m. device. I brought the remarks of the Field Safety Notice concerning the safety of the subject devices as well as proposed precautions to the attention of the user of the device.
Name (blockletters) Date Position Signature
Contact Information (if different as above) Contact Name
Facility E-mail Address Centre/Department Adress Line 1 Adress Line 2 City
Zip/Postal Code Country
