Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 16, 2015
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital
A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen funct…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Visicu, Inc. recalled The eCareManager system. Software intended for use in data collection, storage and clini… - a moderate-severity action.
The eCareManager system. Software intended for use in data collection, storage and clini… was recalled by Visicu, Inc. in December 16, 2015. Reason: A software defect may cause incorrect medication order change. If the user decides to edit the order prior t…. Check the official notice for the remedy. Verify recall #Z-0399-2016 with the FDA Devices before acting.
The recall
Visicu, Inc. issued this moderate-severity FDA Devices recall-A software defect may cause incorrect medication order change. If the user decides to edit the order prior t….
- Moderate
- severity level
- 43 units
- affected scope
- Class II
- classification
- December 16, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0399-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0399-2016) was formally reported on December 16, 2015, with the manufacturer initiating the action on March 27, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Visicu, Inc. is listed as the recalling firm, operating out of Baltimore, MD. Federal records list the affected scope as 43.
The documented reason for this recall is: A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication … Distribution data in the federal record shows the product reached: US distribution only.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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
43
Related Recalls
6
3 from same agency
Product description
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
Reason for recall
A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0399-2016 |
| Date reported | December 16, 2015 |
| Date initiated | March 27, 2015 |
| Recalling firm | Visicu, Inc. |
| Firm location | Baltimore, MD |
| Affected scope | 43 |
| Distribution | US distribution only. |
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-0399-2016) 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? ▼
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.. Recalled by Visicu, Inc.. Units affected: 43.
Why was this product recalled? ▼
A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0399-2016.
Where was the recalled product distributed? ▼
Distribution: US distribution only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0399-2016) 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 December 16, 2015. 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 July 2026.