Reported Nov 13, 2024 · Ongoing
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
- Lot codes and dates
- Software VersionsSoftware Version V2.1.0, Release Date 12-Aug-2019 Connex Cardio Software Version V1.0.0 V1.1.1 18-Oct-2017
- Units1) UDI/DI 00817655022598
- Serial Numbers
625 of 625 codes
117460595592117460595593117500601372117500601373117500601374117500601375118040607879118040607880118070613199117500601376118070613204118070613205118070613206118070613207118290000487118340002360118350000586118350000874118420000133118420001242118420001243118420001244118420001245118420001246118420001247118420001248118440000341118440000343118440000344118440000345118440000346118440000347118440000348118440000349118440000350118440000351118440000352118440000353118440000354118440000355118440000416118440000417118440000418118440000419118440000420118440000421118440000422118440000423118440000424118440000425118440000426118440000427118440000428118440000429118440000430118440000431118440000432118440000433118440000434118440000435
- Serial Numbers
745 of 745 codes
118070613209118070613210118080615506118080615507118080615508118080615509118080615510118080615511118080615512118100617237118100617238118100617239118100617240118100617241118100617242118100617243118100617244118100617245118100617246118100617247118100617249118100617250118100617251118100617252118100617253118100617254118100617255118100617256118100617257118100617258118100617259118100617260118100617261118100617262118100617263118100617264118100617265118100617266118100617267118100617268118100617269118100617270118100617271118100617272118100617273118100617274118100617248118250001251118250001252118250001255118250001256118250001257118250001258118250001259118250001260118250001261118250001262118250001263118250001264118250001265
- Amount recalled
- 1369 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Baxter Healthcare Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.