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Recall Observatory FDA recall evidence

Device product

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

Z-0838-2025

November 05, 2024

Class II

Product summary

Firm
NOA Medical Industries Inc
Event
Event 95971
Status
Ongoing
Classification
Class II
Quantity
34 units
Official record key
device-enforcement:Z-0838-2025

Official wording

Reason: Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.

Code information: UDI/DI 00817492012745, Serial Numbers: 2038043534, 2038042756, 2038042755, 2038042750, 2038042751, 2038042752, 2038042753, 2038042754, 2038042757, 2038042244, 2038041722, 2038038738, 2038038750, 2038038749, 2038038748, 2038038747, 2038038746, 2038038745, 2038038744, 2038038758, 2038038757, 2038038756, 2038038754, 2038038753, 2038038752, 2038038755, 2038038743, 2038038742, 2038038737, 2038038751, 2038038739, 2038038740, 2038038741, 2038038766.

Distribution pattern: US: GA, MI. MA, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.