Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 26, 2017
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draegar Medical Systems, Inc. recalled Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31… - a moderate-severity action.
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31… was recalled by Draegar Medical Systems, Inc. in July 26, 2017. Reason: Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual ala…. Check the official notice for the remedy. Verify recall #Z-2734-2017 with the FDA Devices before acting.
The recall
Draegar Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual ala….
- Moderate
- severity level
- Class II
- classification
- July 26, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2734-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2734-2017) was formally reported on July 26, 2017, with the manufacturer initiating the action on June 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Draegar Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 37 US and 682 OUS.
The documented reason for this recall is: Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. Distribution data in the federal record shows the product reached: AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fe…. 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 - 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 - 40,422 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
37 US and 682 OUS
Related Recalls
6
0 from same agency
Product description
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Reason for recall
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2734-2017 |
| Date reported | July 26, 2017 |
| Date initiated | June 6, 2017 |
| Recalling firm | Draegar Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 37 US and 682 OUS |
| Distribution | AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa So… |
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-2734-2017) 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? ▼
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recalled by Draegar Medical Systems, Inc.. Units affected: 37 US and 682 OUS.
Why was this product recalled? ▼
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2734-2017.
Where was the recalled product distributed? ▼
Distribution: AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2734-2017) 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 July 26, 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.