The Recall Desk
HighFDA (Devices)·Z-0661-2022·Announced 2022-03-02

Video Camera Ceiling Tile Kits May Fall in Some Installations

Natus Neurology is recalling IPELA FHD PTZ tile kits that may not fit properly in thinner ceiling tile grids and could suddenly fall, creating a safety hazard.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (falling ceiling-mounted equipment) presents credible risk of harm but injury has not yet been reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

Natus Neurology (DBA Excel Tech., Ltd./XLTEK) is recalling IPELA FHD PTZ tile kits with Axis cameras used with Natus Neuroworks and Sleepworks software. These kits are designed to install and position video cameras within patient environments.

The tile kits do not fit properly in some institution ceiling tile grids that have a thinner-style frame. When incompatible with the ceiling grid frame, a ceiling tile containing the camera kit may suddenly fall from the ceiling, posing a safety risk to patients and end users.

A total of 221 units have been distributed worldwide. Individuals who believe they have an affected unit should contact the manufacturer for further guidance.

The recalled product

Product
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Manufacturer
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Category
Medical Device — Patient Monitoring Equipment
Hazard
  • falling-object
  • installation-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

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