Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 17, 2016
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generat
Incorrect CO2 readings with some patient monitors.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Edan Diagnostics recalled EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A,… - a moderate-severity action.
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A,… was recalled by Edan Diagnostics in August 17, 2016. Reason: Incorrect CO2 readings with some patient monitors.. Check the official notice for the remedy. Verify recall #Z-2388-2016 with the FDA Devices before acting.
The recall
Edan Diagnostics issued this moderate-severity FDA Devices recall-Incorrect CO2 readings with some patient monitors..
- Moderate
- severity level
- 521 units
- affected scope
- Class II
- classification
- August 17, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2388-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2388-2016) was formally reported on August 17, 2016, with the manufacturer initiating the action on June 23, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Edan Diagnostics is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 521.
The documented reason for this recall is: Incorrect CO2 readings with some patient monitors. Distribution data in the federal record shows the product reached: Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Repub…. 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
521
Related Recalls
6
3 from same agency
Product description
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
Reason for recall
Incorrect CO2 readings with some patient monitors.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2388-2016 |
| Date reported | August 17, 2016 |
| Date initiated | June 23, 2016 |
| Recalling firm | Edan Diagnostics |
| Firm location | San Diego, CA |
| Affected scope | 521 |
| Distribution | Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Mala… |
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-2388-2016) 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? ▼
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).. Recalled by Edan Diagnostics. Units affected: 521.
Why was this product recalled? ▼
Incorrect CO2 readings with some patient monitors.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2388-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Sudan, Senegal, Sri Lanka, Thailand, Turkey, United Kingdom, and Uruguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2388-2016) 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 August 17, 2016. 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.