Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 5, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draeger Medical Systems, Inc. recalled Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is i… - a moderate-severity action.
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is i… was recalled by Draeger Medical Systems, Inc. in February 5, 2025. Reason: Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can…. Check the official notice for the remedy. Verify recall #Z-1066-2025 with the FDA Devices before acting.
The recall
Draeger Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- February 5, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1066-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1066-2025) was formally reported on February 5, 2025, with the manufacturer initiating the action on January 14, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Draeger Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 1,013 units.
The documented reason for this recall is: Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, NE, NY, OK, PA, SD, TN, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Botswana, Brazi…. 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
1,013 units
Related Recalls
6
3 from same agency
Product description
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
Reason for recall
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1066-2025 |
| Date reported | February 5, 2025 |
| Date initiated | January 14, 2025 |
| Recalling firm | Draeger Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 1,013 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, NE, NY, OK, PA, SD, TN, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Botswana, Brazil, Canada, Chile, Ch… |
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-1066-2025) 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? ▼
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.. Recalled by Draeger Medical Systems, Inc.. Units affected: 1,013 units.
Why was this product recalled? ▼
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1066-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, NE, NY, OK, PA, SD, TN, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kenya, Malaysia, Mexico, Monaco, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Samoa, American, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkiye, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1066-2025) 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 February 5, 2025. 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.