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Recall Observatory FDA recall evidence

Device product

SAROS Oxygen System Model 3000

Z-0248-2020

September 16, 2019

Class II

Product summary

Firm
Caire, Inc.
Event
Event 83850
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0248-2020

Official wording

Reason: There is an electronics control issue that causes the unit to not power on with battery power only.

Code information: Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052

Distribution pattern: US and Chile

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is an electronics control issue that causes the unit to not power on with battery power only.