CLASS II Device recall · Reported 2 Mar 2022 · FDA Enforcement Report
Ipela Fhd Ptz Tile Kits with Axis cameras used recalled
Natus Neurology is recalling Ipela Fhd Ptz Tile Kits with Axis cameras used in combination with Natus, distributed nationwide in the US. The recall was initiated on 2 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0661-2022
- FDA event ID
- 89425
- Recalling firm
- Natus Neurology, Oakville
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2021
- FDA classified
- 22 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 2 Dec 2021 | Recall initiated by company | |
| 22 Feb 2022 | Classified by FDA | +82 days |
| 2 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, MI, MA, NE, OK, WV, MO, VA, CT, IN, HI, PA, CA, MD, OH, CO, SC, PR, NV, NJ, OR, LA, DC, NC and the countries of Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic of
Nationwide CaliforniaColoradoConnecticutDistrict of ColumbiaFloridaHawaiiIllinoisIndianaLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNebraskaNew JerseyNevadaOhioOklahomaOregon
Questions about this recall
Why was it recalled?
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.
Which lots are affected?
All serial numbers
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, MI, MA, NE, OK, WV, MO, VA, CT, IN, HI, PA, CA, MD, OH, CO, SC, PR, NV, NJ, OR, LA, DC, NC and the countries of Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic of
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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