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Recalls Announced on Defibtech AED, Sea Elite BCD
The FDA and the U.S. Consumer Product Safety Commission today announced two recalls of equipment that may be used by first responders: Lifeline AED and ReviveR DDU-100 series AEDs, manufactured by Defibtech, LLC, and the Scout and Profile models of buoyancy control devices (BCDs) manufactured by Sea Elite Systems. The information on both recalls follows.
Lifeline AED and ReviveR DDU-100 series AEDs
Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.
Condition 1: In rare instances, the AED may cancel charge in preparation for a shock. Based on field data, the odds of an affected AED having this happen are less than a 1 in 400,000 chance per month for any given AED.
A subset of AEDs (less than 11%) that are affected by Condition 1 are also affected by Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions. The only reported cases were in environments of greater than 95% relative humidity or condensing conditions. Based on field data, the odds of an affected AED having this happen are less than a 1 in 250,000 chance per month for any given affected AED.
Defibtech will provide customers with a free software upgrade to address these issues. The correction to the AED will be able to be performed at the location where the AED is deployed.
Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade. Full instructions and recommendations are being mailed to affected customers. This customer notification, as well as instructions on determining whether an AED is affected, can also be found at www.defibtech.com/fa11. For additional information regarding this recall, please refer to the above referenced web page, contact your distributor, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.
The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.
Sea Elite Scout and Profile Model BCDs
The U.S. Consumer Product Safety Commission and Health Canada, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: Sea Elite Systems Buoyancy Control Devices (BCD)
Units: About 405 in the U.S. and 48 in Canada
Importer: WRK Enterprises dba Edge Dive Gear of Macon, Ga.
Hazard: The spring in the over pressure valve can corrode and break preventing the buoyancy control device from retaining air, posing a drowning hazard to consumers.
Incidents/Injuries: None
Description: This recall affects Sea Elite Scout and Profile model BCDs.The Scout is a jacket-style BCD made of lightweight nylon and is foldable. It is black with blue accents on the lower sides. The word "Scout" is printed in white letters on the right front and the words "Sea Elite" are on a flap over the corrugated hose. Scout BCDs within the following serial number ranges are affected by this recall: 001229 to 001244 and 001246 to 001489. The serial number is printed on a tag in the front pocket.
The Profile is a jacket-style BCD made of heavyweight nylon. It is black with blue on the lower sides. The word "Profile" is printed in white letters on the right front and the words "Sea Elite" are on a flap over the corrugated hose. Profile BCDs with serial numbers in the table below are affected by this recall.
Sea Elite Profile BCD Serial Numbers (The serial number is printed on a tag in the front pocket.)
000700 to 000729
000733 to 000763
000765 to 000772
000879
001490 to 001560
001562 to 001565
Sold at: Divers Supply Store locations nationwide and online at www.divers-supply.com in Canada from May 2009 through October 2010 for about $199 to $250
Manufactured in: China
Remedy: Consumers should immediately stop using the BCDs and return them to an authorized Sea Elite Systems dealer for a free spring replacement at no charge.
Consumer Contact: For additional information, contact Chris Richardson at 888-370-3483 between 9 a.m. and 5 p.m. ET, Monday through Friday, or visit the Edge Dive Gear website at www.edge-gear.com.
Lifeline AED and ReviveR DDU-100 series AEDs
Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.
Condition 1: In rare instances, the AED may cancel charge in preparation for a shock. Based on field data, the odds of an affected AED having this happen are less than a 1 in 400,000 chance per month for any given AED.
A subset of AEDs (less than 11%) that are affected by Condition 1 are also affected by Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions. The only reported cases were in environments of greater than 95% relative humidity or condensing conditions. Based on field data, the odds of an affected AED having this happen are less than a 1 in 250,000 chance per month for any given affected AED.
Defibtech will provide customers with a free software upgrade to address these issues. The correction to the AED will be able to be performed at the location where the AED is deployed.
Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade. Full instructions and recommendations are being mailed to affected customers. This customer notification, as well as instructions on determining whether an AED is affected, can also be found at www.defibtech.com/fa11. For additional information regarding this recall, please refer to the above referenced web page, contact your distributor, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.
The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.
Sea Elite Scout and Profile Model BCDs
The U.S. Consumer Product Safety Commission and Health Canada, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: Sea Elite Systems Buoyancy Control Devices (BCD)
Units: About 405 in the U.S. and 48 in Canada
Importer: WRK Enterprises dba Edge Dive Gear of Macon, Ga.
Hazard: The spring in the over pressure valve can corrode and break preventing the buoyancy control device from retaining air, posing a drowning hazard to consumers.
Incidents/Injuries: None
Description: This recall affects Sea Elite Scout and Profile model BCDs.The Scout is a jacket-style BCD made of lightweight nylon and is foldable. It is black with blue accents on the lower sides. The word "Scout" is printed in white letters on the right front and the words "Sea Elite" are on a flap over the corrugated hose. Scout BCDs within the following serial number ranges are affected by this recall: 001229 to 001244 and 001246 to 001489. The serial number is printed on a tag in the front pocket.
The Profile is a jacket-style BCD made of heavyweight nylon. It is black with blue on the lower sides. The word "Profile" is printed in white letters on the right front and the words "Sea Elite" are on a flap over the corrugated hose. Profile BCDs with serial numbers in the table below are affected by this recall.
Sea Elite Profile BCD Serial Numbers (The serial number is printed on a tag in the front pocket.)
000700 to 000729
000733 to 000763
000765 to 000772
000879
001490 to 001560
001562 to 001565
Sold at: Divers Supply Store locations nationwide and online at www.divers-supply.com in Canada from May 2009 through October 2010 for about $199 to $250
Manufactured in: China
Remedy: Consumers should immediately stop using the BCDs and return them to an authorized Sea Elite Systems dealer for a free spring replacement at no charge.
Consumer Contact: For additional information, contact Chris Richardson at 888-370-3483 between 9 a.m. and 5 p.m. ET, Monday through Friday, or visit the Edge Dive Gear website at www.edge-gear.com.
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