Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for medical device software that may assign duplicate identifiers to exam files. While no illnesses or injuries have been reported, this creates a risk-of-harm scenario where patient identification could be mismatched with physiological data, potentially leading to incorrect diagnosis.
Plain-English summary
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio) diagnostic spirometers are being recalled due to a software issue that may cause exam files to be assigned duplicate Unique Identifiers (UIDs).
The problem occurs when medical imaging systems such as Picture Archiving and Communication Systems (PACS) rely solely on the UID to identify exam records. Duplicate UIDs could cause patient identification data to be mismatched with physiological data, creating a risk that diagnostic results may be linked to the wrong patient record.
Approximately 1,369 units have been distributed worldwide. The affected devices were manufactured by Baxter Healthcare Corporation and have specific serial numbers listed in the recall notice.
No illnesses or injuries have been reported related to this issue. The manufacturer is managing the recall.
The recalled product
- Product
- Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,369
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Software Versions: Software Version V2.1.0
- Serial Numbers: 117460595592
- 117460595593
- 117500601372
- 117500601373
- 117500601374
- 117500601375
- 118040607879
- 118040607880
- 118070613199
- 117500601376
- 118070613204
- 118070613205
- 118070613206
- 118070613207
- 118290000487
- 118340002360
- 118350000586
- 118350000874
- 118420000133
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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