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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmSeptember 11, 2019
Create DateMarch 02, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1154-2020
Recall Event ID 83980
510(K)NumberK082660 
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
ProductRespironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
Code Information Touchscreen Serial Number: 41088-1808-0001 to 0179,  41213-1809-0001 to 0200,  41305-1811-0001 to 0295,  41379-1812-0001 to 0250,  41379-1812-0251 to 0328,  41540-1813-0001 to 0195,  41633-1814-0001 to 0275,  41633-1814-0276 to 0285,  41724-1815-0001 to 0140,  41724-1815-0141 to 0183,  41838-1816-0001 to 0107,  41838-1816-0108 to 0165,  41930-1817-0001 to 0092,  42059-1818-0001 to 0150,  42059-1818-0151 to 0183,  42161-1819-0001 to 0117,  42161-1819-0118 to 0137,  42232-1820-0001 to 0130,  42232-1820-0131 to 0146,  42334-1822-0001 to 0134,  42334-1822-0135 to 0141,  42471-1823-0001 to 0143,  42471-1823-0144 to 0175,  42805-1828-0001 to 0138  
Recalling Firm/
Manufacturer		 Respironics California, LLC
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact
760-918-7300
Manufacturer Reason
for Recall		Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
FDA Determined
Cause 2		Other
ActionOn 09/26/19, Urgent Medical Device Correction Field Safety Notices were mailed to customers. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Ventilator): 1) If in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If a touchscreen failure is detected, disconnect the patient and immediately start ventilation with an alternate device. Contact your local customer service representative to report the failure. 3) To minimize the risk of patient injury, operate the Ventilator as defined in the operator's manual and promptly attend to all alarms presented by the ventilator. 4) As recommended in the operator's manual, use an external 02 monitor/analyzer and set the alarm thresholds appropriately. 5) As recommended in the operator's manual, have an alternative means of ventilation available whenever the ventilator is in use. 6) Acknowledge receipt of this notification. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (User Interface RP-Kits): 1) If the affected kit is installed on a ventilator and in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If the affected kit is installed on a ventilator, document the serial number of the ventilator and the serial number of the affected User Interface Assembly it contained, on the attached Acknowledgement and Receipt Form. 3) If the affected devices could not be found or linked to a ventilator at your site, please indicate this within in the detail section provided on the form, 4) Return the completed and signed Acknowledgement and Receipt Form. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Tou
Quantity in Commerce800
DistributionUS Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MNT
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