FDA Medical Device Recalls (openFDA)
Randox Laboratories, Limited: RX Imola, Model Nos. RX4900
- Recall number
- Z-2084-2019
- Recalling firm
- Randox Laboratories, Limited
- Product
- RX Imola, Model Nos. RX4900
- Status
- Terminated
- Initiated
- 2019-06-24
- Posted
- not on file
- Terminated
- 2020-05-21
- Reason
- There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
- Root cause
- Under Investigation by firm
- Action
- On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
- Quantity
- 27
- Distribution
- Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K052914"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28