🔍 RecallPedia

Respironics V680 Ventilator, Service # 850011, (OUS Only)

Class I - Dangerous
🏥 Medical Devices Recalled: September 11, 2019 Respironics California Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Respironics California, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Respironics V680 Ventilator, Service # 850011, (OUS Only)

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1155-2020

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