Date Initiated by Firm | May 28, 2019 |
Date Posted | June 21, 2019 |
Recall Status1 |
Terminated 3 on July 10, 2023 |
Recall Number | Z-1857-2019 |
Recall Event ID |
82978 |
510(K)Number | K130513 |
Product Classification |
Lamp, surgical - Product Code FTD
|
Product | Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229000A
Model: VST60SF AIM |
Code Information |
Serial Numbers: 500000 500001 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular Us Sales, Llc 45 Barbour Pond Dr Wayne NJ 07470-2094
|
For Additional Information Contact | 973-709-7000 |
Manufacturer Reason for Recall | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk
of particles falling into the surgical field during surgery that may result in patient infection |
FDA Determined Cause 2 | Device Design |
Action | Getinge/Maquet SAS issued on 5/28/19 Urgent Medical Correction letter via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD).
Letter provides identification of issue, health risk and action to take: Before using the VOLISTA StandOP, please inspect the forks and check if cracks on the coating are visible as instructed in the VOLISTA StandOP manual; If a coating crack is detected, please STOP USING the VOLISTA StandOP and contact your Getinge representative. Complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM . Return the completed form to Maquet/Getinge by e-mailing a scanned copy to VOLISTAFork2019@getinge.com or by faxing the form to 1-707-202-7275;A Getinge Sales or Service representative will contact you to schedule inspection and correction if necessary of the VOLISTA StandOP SURGICAL LIGHTS at your facility.
For technical questions, contact Technical Support Department at
1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
***Updated 3/30/2020***
On March 30, 2020, the firm sent an new letter to customers, informing them of an update to the corrective actions previously communicated. The firm has developed an interim solution for affected devices.
The solution consists of a validated adhesive strip that is resistant to mechanical stresses and compatible with typical chemical agents used in the operating rooms. The solution allows customers to continue using their lights until their defective forks are replaced. The interim solution will be applied by a Getinge representative.
A Getinge Sales or Service representative will contact customers to schedule inspection and correction (if necessary) of affected devices at each facility. If your site has already been contacted to schedule an inspection, the work above will be performed during that scheduled visit. |
Quantity in Commerce | 2 units |
Distribution | Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA
AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA
AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA
BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA
BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN
CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND
COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES
CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FTD
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