FDA Medical Device Recalls (openFDA)
Radiometer Medical ApS: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
- Recall number
- Z-1836-2020
- Recalling firm
- Radiometer Medical ApS
- Product
- ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
- Status
- Open, Classified
- Initiated
- 2020-03-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
- Root cause
- Component design/selection
- Action
- On 3/5/2020 a "Urgent: Medical device Recall" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions: Solution provided by Radiometer: 1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience. Your Actions: 1. Cease using the affected ABL800 analyzer and put it on quarantine. 2. Shut down the affected ABL800 analyzer and disconnect the power cord. 3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative 4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.
- Quantity
- 2 units
- Distribution
- US: in the state of California
- Lot, serial or model codes
- Serial Numbers: 902-754R2692N002 and 902-754R2692N001
- 510(k) numbers
- ["K041874"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3002807968
- Firm city
- Bronshoj
- Firm state
- not on file
- Firm country
- Denmark
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