Reported Oct 1, 2014 · Terminated

Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models…

Spacelabs Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spacelabs Healthcare Inc · 35301 SE Center St · Snoqualmie, WA · 98065-9216

Is this the product you have?

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

Lot codes and dates: 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 US040-1548-00, 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
137 of 137 codes
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
Amount recalled: 82 units distributed in US and 140 units distributed outside US

Where it was sold

Nationwide
PR
FL
GA
IA
KY
LA
MA
MI
MN
MO
MS
NJ
NY
OH
OK
PA
SC
TN
TX
WA

Why it was 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).

This product could cause temporary or reversible health problems — stop using it.

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Medical device recalls

Other recalls from Spacelabs Healthcare Inc.

16 in total.

Where it was distributed

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