Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia… recallZ-2161-2013 · GE Healthcare, LLC · initiated Jul 29, 2013

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to

FDA root cause category: Component change control

What the company is doing

GE Healthcare sent an Urgent Medical Device Correction letter dated August 1, 2013, to all affected customers. The letter described the issue, asked that the Tec 6 and Tec 6 Plus Vaporizers user manual be updated with the attached addendum. Also Users are to perform the user manual recommended pre-operative check which includes the low pressure leak test on every vaporizer with the dial turned to the 12% setting instead of the specified 1% setting as per the attached addendum. If the device does not pass the new low pressure leak at 12%, it should be removed from service and consignee should ontact a GE Healthcare Representative for a repair/replacement. If the vaporizer passes the new low pressure leak test at the 12 % setting, it can continue to be used, however, as detailed in the user manual, continue to routinely perform the pre-operative check which includes the low pressure leak test.A Medical Device Correction Confirmation form was asked to be sent back to GE. Customers with questions or concerns were instructed to call 1-855-700-4350 or send an email to [email protected]. For countries outside the US, customers were instructed to contact their local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Recall details

Recall number

Z-2161-2013

Recall class

Class II

Status

Terminated

Initiated by the company

Jul 29, 2013

Posted by the FDA

Sep 6, 2013

Recalling firm

GE Healthcare, LLC

Quantity

31,443 devices (23,947 US, 7496 OUS)

Product code

BSZ

FDA submissions

K000275, K925580

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA local name-Hrvatska, CYPRUS, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA-REPUBLIC OF, KUWAIT, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA,

Product description

Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

Other devices under the same FDA submission

3 devices cleared under K000275, K925580 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• TEC 6 PLUS VAP DES 120V ES

  Datex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED
  1 recall63 reports
• TEC 6 PLUS VAP DES 220/240V EN

  Datex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED
  1 recall48 reports
• TEC 6 PLUS VAP DES 120V USA

  Datex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED
  36 reports