FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
- Recall number
- Z-2320-2019
- Recalling firm
- Radiometer America Inc
- Product
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
- Status
- Terminated
- Initiated
- 2019-07-10
- Posted
- 2019-08-22
- Terminated
- 2022-06-13
- Reason
- Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
- Root cause
- Software design
- Action
- On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following your analyzer is affected by the vulnerability: RXPE - UIM2743 v1.3.xxxxxx or RXPE-UIM910v1.3.xxxxxx 2. If your analyzer is found to be affected by the vulnerability the following options must be applied: Short term: If your analyzer is connected to a network and your IT department assesses that the Hospital Firewall and Network settings prevent a remote attacker from connecting to the analyzer to exploit the vulnerability, you may decide to keep the analyzer connected. Otherwise, we recommend disconnecting it until one of the long term countermeasures below has been implemented. Long term: Countermeasure 1: Contact your Radiometer representative to have the RXPE Security patch update installed on your analyzer. (Note: Microsoft does not support Windows XP anymore. However, Microsoft has extraordinarily released a patch for this particular vulnerability.) or Countermeasure 2: Contact your Radiometer representative to receive a quote for an upgrade to latest OS (Windows 7 embedded) from Radiometer, which is supported by Microsoft. 3.Please complete the Recall Response Form (last page of the customer advisory letter) and return it to your Radiometer representative. 4.Please Note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. If you have questions, please contact Radiometer
- Quantity
- 13,042 units
- Distribution
- US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
- Lot, serial or model codes
- All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
- 510(k) numbers
- ["K092686"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 3010420736
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
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