Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 14, 2017
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the de…
Circadiance LLC recalled SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuou… - a moderate-severity action.
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuou… was recalled by Circadiance LLC in June 14, 2017. Reason: Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermit…. Check the official notice for the remedy. Verify recall #Z-2250-2017 with the FDA Devices before acting.
The recall
Circadiance LLC issued this moderate-severity FDA Devices recall-Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermit….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- June 14, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2250-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2250-2017) was formally reported on June 14, 2017, with the manufacturer initiating the action on May 1, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Circadiance LLC is listed as the recalling firm, operating out of Export, PA. Federal records list the affected scope as 1,242 units.
The documented reason for this recall is: Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" featur… Distribution data in the federal record shows the product reached: Nationwide Distribution.. 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
1,242 units
Related Recalls
6
3 from same agency
Product description
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
Reason for recall
Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2250-2017 |
| Date reported | June 14, 2017 |
| Date initiated | May 1, 2017 |
| Recalling firm | Circadiance LLC |
| Firm location | Export, PA |
| Affected scope | 1,242 units |
| Distribution | Nationwide Distribution. |
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-2250-2017) 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? ▼
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.. Recalled by Circadiance LLC. Units affected: 1,242 units.
Why was this product recalled? ▼
Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2250-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2250-2017) 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 14, 2017. 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.