Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 9, 2013
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mindray Ds USA, Inc. d.b.a. Mindray North America recalled DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 Th… - a moderate-severity action.
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 Th… was recalled by Mindray Ds USA, Inc. d.b.a. Mindray North America in January 9, 2013. Reason: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe …. Check the official notice for the remedy. Verify recall #Z-0630-2013 with the FDA Devices before acting.
The recall
Mindray Ds USA, Inc. d.b.a. Mindray North America issued this moderate-severity FDA Devices recall-There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe ….
- Moderate
- severity level
- Class II
- classification
- January 9, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0630-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0630-2013) was formally reported on January 9, 2013, with the manufacturer initiating the action on May 12, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Mindray Ds USA, Inc. d.b.a. Mindray North America is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as two units.
The documented reason for this recall is: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient. Distribution data in the federal record shows the product reached: Nationwide Distribution including OH and GA. 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
two units
Related Recalls
6
3 from same agency
Product description
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
Reason for recall
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0630-2013 |
| Date reported | January 9, 2013 |
| Date initiated | May 12, 2011 |
| Recalling firm | Mindray Ds USA, Inc. d.b.a. Mindray North America |
| Firm location | Mahwah, NJ |
| Affected scope | two units |
| Distribution | Nationwide Distribution including OH and GA |
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-0630-2013) 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? ▼
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.. Recalled by Mindray Ds USA, Inc. d.b.a. Mindray North America. Units affected: two units.
Why was this product recalled? ▼
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 9, 2013. Severity: Moderate. Recall number: Z-0630-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including OH and GA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0630-2013) 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 January 9, 2013. 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.