Z-1153-2020Class II

Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941...

Name: Z-1153-2020 Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941...
Creator: Respironics California, LLC
Published: 2019-09-11
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2019-09-11 / Open, Classified

FDA source

Respironics California, LLC began a recall of Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461 on 2019-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1153-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-11
Posted: 2020-03-02
Recalling firm: Respironics, Inc.
Product: Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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 root cause: Other
Action: On 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 commerce: 56
Distribution: US 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
Product codes and lots: Serial Numbers: 100270400, 100270407, 100256220, 100270404, 100263004, 100266507, 100270402, 100263001, 100263009, 100258193, 100258197, 100258883, 100262978, 100263006, 100258196, 100256196, 100256197, 100256198, 100263003, 100266499, 100266505, 100258889, 100256192, 100258887, 100266509, 100270408, 100262976, 100258881, 100258880, 100266511, 100270406, 100258885, 100256223, 100263000, 100258884, 100258888, 100266500, 100266504, 100258886, 100256222, 100256195, 100256199, 100266502, 100266508, 100266510, 100270403, 100270490, 100257708, 100257713, 100257716, 100256831, 100256834, 100256837, 100262373, 100262556, 100262575, 100265136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1153-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1152-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1153-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1154-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12
Z-1155-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code MNT

K082660Class IIV60 Ventilator, Model V8000Respironics California, Inc. / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)