Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 5, 2019
Horizon Cardiology Hemo
users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" …
Change Healthcare Israel Ltd. recalled Horizon Cardiology Hemo - a moderate-severity action.
Horizon Cardiology Hemo was recalled by Change Healthcare Israel Ltd. in June 5, 2019. Reason: users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes…. Check the official notice for the remedy. Verify recall #Z-1489-2019 with the FDA Devices before acting.
The recall
Change Healthcare Israel Ltd. issued this moderate-severity FDA Devices recall-users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes….
- Moderate
- severity level
- 125 units
- affected scope
- Class II
- classification
- June 5, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1489-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1489-2019) was formally reported on June 5, 2019, with the manufacturer initiating the action on March 25, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Change Healthcare Israel Ltd. is listed as the recalling firm, operating out of Holon, N/A. Federal records list the affected scope as 125 devices.
The documented reason for this recall is: users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect… Distribution data in the federal record shows the product reached: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. Internati…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
125 devices
Related Recalls
6
6 from same agency
Product description
Horizon Cardiology Hemo
Reason for recall
users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1489-2019 |
| Date reported | June 5, 2019 |
| Date initiated | March 25, 2019 |
| Recalling firm | Change Healthcare Israel Ltd. |
| Firm location | Holon, N/A |
| Affected scope | 125 devices |
| Distribution | Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. International distribution to… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1489-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Horizon Cardiology Hemo. Recalled by Change Healthcare Israel Ltd.. Units affected: 125 devices.
Why was this product recalled? ▼
users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1489-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. International distribution to Australia, Canada, Germany, Ireland, Israel, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1489-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 5, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.