Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 1, 2014
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products
The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective ana…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare Inc recalled Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Det… - a moderate-severity action.
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Det… was recalled by Spacelabs Healthcare Inc in October 1, 2014. Reason: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarm…. Check the official notice for the remedy. Verify recall #Z-2707-2014 with the FDA Devices before acting.
The recall
Spacelabs Healthcare Inc issued this moderate-severity FDA Devices recall-The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarm….
- Moderate
- severity level
- 82 units
- affected scope
- Class II
- classification
- October 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2707-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2707-2014) was formally reported on October 1, 2014, with the manufacturer initiating the action on August 26, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare Inc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records list the affected scope as 82 units distributed in US and 140 units distributed outside US.
The documented reason for this recall is: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and disc… Distribution data in the federal record shows the product reached: Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Can…. 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
82 units distributed in US and 140 units distributed outside US
Related Recalls
6
3 from same agency
Product description
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
Reason for recall
The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2707-2014 |
| Date reported | October 1, 2014 |
| Date initiated | August 26, 2014 |
| Recalling firm | Spacelabs Healthcare Inc |
| Firm location | Snoqualmie, WA |
| Affected scope | 82 units distributed in US and 140 units distributed outside US |
| Distribution | Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Re… |
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-2707-2014) 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? ▼
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Recalled by Spacelabs Healthcare Inc. Units affected: 82 units distributed in US and 140 units distributed outside US.
Why was this product recalled? ▼
The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2014. Severity: Moderate. Recall number: Z-2707-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2707-2014) 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 October 1, 2014. 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.