FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare Inc: 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
- Recall number
- Z-2707-2014
- Recalling firm
- Spacelabs Healthcare Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2014-08-26
- Posted
- 2014-09-25
- Terminated
- 2015-06-26
- Reason
- 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).
- Root cause
- Environmental control
- Action
- Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION (Expanded)" letter dated 5 September 2014 to all consignees in the US. This letter identified recalled model 91367, 91369, 91370, 91387, and 91393, Upgrade Kit 040-1548-00, Equipped with the Perioperative Option (-D), problem, and actions to be taken. On September 12, 2014, a recall notification letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The firm's Field Service Engineers will contact customers to schedule a time to come out to update affected monitors at no cost. Customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025.
- Quantity
- 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 Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
- Lot, serial or model codes
- The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed. THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US: 040-1548-00, 1367-000033, 1369-001517, 1369-003051, 1369-003077, 1369-004247, 1369-005914, 1369-006877, 1369-007165, 1369-008519, 1369-010292, 1369-011637, 1369-017520, 1369-061217, 1370-000013, 1370-000014, 1370-000025, 1370-000095, 1370-000285, 1370-000449, 1370-000471, 1370-000579, 1370-000658, 1370-001700, 1370-002494, 1370-002510, 1370-003785, 1370-004176, 1370-004184, 1370-004275, 1370-004292, 1387-000465, 1387-000535, 1387-000543, 1387-001071, 1387-001677, 1387-006200, 1387-010824, 1387-010830, 1387-011914, 1387-014142, 1387-014159, 1387-014184, 1387-014186, 1387-014187, 1387-014188, 1387-014596, 1387-015721, 1387-015722, 1387-015723, 1387-016045, 1387-018424, 1387-018947, 1387-019766, 1387-019768, 1387-019769, 1387-019771, 1387-019772, 1387-100036, 1387-101646, 1387-104672, 1387-105801, 1387-105811, 1387-105812, 1387-105882, 1393-000442, 1393-000579, 1393-000580, 1393-000581, 1393-000582, and 387-002421. THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US: 1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 1370-200378, 1370-200380, 1370-200471, 1370-200473, 1370-200474, 1370-200475, 1370-200476, 1370-200691, 1387-000044, 1387-000447, 1387-000467, 1387-000548, 1387-001086, 1387-002157, 1387-005006, 1387-008003, 1387-008310, 1387-010742, 1387-013241, 1387-013716, 1387-014610, 1387-018104, 1387-018105, 1387-018171, 1387-018176, 1387-018277, 1387-018638, 1387-018817, 1387-019563, 1387-100148, 1387-100150, 1387-100151, 1387-100155, 1387-100906, 1387-101061, 1387-101062, 1387-101063, 1387-101064, 1387-101065, 1387-101066, 1387-101067, 1387-102222, 1387-103550, 1387-103659, 1387-104462, 1387-105831, 1387-105832, 1387-105833, 1387-105834, 1393-000013, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000808, 1393-000809, 1393-000822, 1393-000831, 1393-000833, 1393-000834, 1393-000851, 1393-000852, 1393-00235, 1393-00236, 1393-00237, 1393-00238, 1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346, 1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351, 1393-00352, 1393-00353, 1393-00354, AND 1393-00355.
- 510(k) numbers
- ["K102422"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28