Respironics California, LLC: Medical Device Recall in 2020 - (Recall #: Z-1155-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Respironics V680 Ventilator, Service # 850011, (OUS Only)
Class II
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.
Serial Numbers: 100255874, 100255957, 100257487, 100257488, 100257490, 100257491, 100257493, 100257494, 100257495, 100257496, 100257497, 100257498, 100257499, 100257500, 100257501, 100258060, 100258061, 100258063, 100258064, 100258065, 100258066, 100258067, 100258068, 100260220, 100260221, 100260222, 100260223, 100260224, 100260227, 100260228, 100260229, 100260616, 100260617, 100260618, 100260619, 100260620, 100260621, 100260622, 100260623, 100260624, 100260625, 100260626, 100260627, 100260628, 100260629, 100260630, 100260631, 100260632, 100260633, 100260634, 100260635, 100261843, 100261844, 100261845, 100261846, 100261847, 100261848, 100261849, 100261850, 100261851, 100261852, 100261853, 100261854, 100261855, 100261856, 100261857, 100261900, 100261901, 100261902, 100263992, 100263993, 100263994, 100263995, 100263996, 100263997, 100263998, 100263999, 100264020, 100264021, 100264022, 100264023, 100264024, 100264025, 100264026, 100264279, 100264300, 100264301, 100264302, 100264303, 100264561, 100264562, 100264563, 100264564, 100264565, 100264566, 100264567, 100264568, 100264569, 100264570, 100264571, 100264572, 100264573, 100264574, 100264575, 100264576, 100264577, 100264578, 100264579, 100264780, 100264781, 100264782, 100264783, 100264784, 100264785, 100265624, 100265625, 100265626, 100265627, 100265628, 100265629, 100265630, 100265631, 100265632, 100265633, 100265634, 100265635, 100265636, 100265637, 100265638, 100265639, 100265640, 100265641, 100265642, 201034917, 201034918, 201034919, 201034945, 201034946, 201034947, 201034949, 201034950, 201034951, 201034952, 201034953, 201034954, 201035015, 201035016, 201035017, 201035018, 201035019, 201035080, 201035081, 201035082, 201035083, 201035084, 201035085, 201035197, 201035198, 201035199, 201035221, 201035222, 201035223, 201035224, 201035225, 201035226, 201035320, 201035321, 201035322, 201035323, 201035324, 201035325, 201035326, 201035328, 201035329, 201035330, 201035331, 201035332, 201035333, 201035334, 201035335, 201035336, 201035337, 201035338, 201035339, 201035360, 201035361, 201035362, 201035363, 201035364, 201035365
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
Voluntary: Firm initiated