Reported Mar 4, 2015 · Terminated
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390),…
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 Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays 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 Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
- Lot codes and dates
- SERIAL NUMBERS OF UNITS IN THE US
2,117 of 2,117 codes
139010490413901049051390-0004201390-0004911390-0005281390-0005311390-0005321390-0007671390-0009381390-0010811390-0013461390-0013511390-1003741390-1005561390-1006231390-1006271390-1006281390-1006291390-1006301390-1006321390-1006331390-1006341390-1007341390-1009871390-1009911390-1010201390-1010711390-1013011390-1014031390-1014231390-1015771390-1018371390-1019371390-1019451390-1019791390-1019991390-1020421390-1022101390-1022161390-1023201390-1024321390-1024451390-1024461390-1024471390-1024481390-1024491390-1024501390-1024511390-1024521390-1024531390-1024541390-1024551390-1024561390-1024571390-1024581390-1025231390-1025651390-1025661390-1025671390-102568
- SERIAL NUMBERS OF UNITS OUTSIDE THE US
385 of 385 codes
1390-0001231390-0005671390-0006131390-0010221390-0010231390-0010241390-0010251390-0010261390-0010271390-0010281390-0010291390-0011021390-0013561390-1000501390-1002021390-1002351390-1002621390-1003941390-1003951390-1003961390-1004471390-1006351390-1010141390-1013371390-1013651390-1014941390-1015681390-1017151390-1017501390-1017681390-1018761390-1018871390-1018901390-1019471390-1019481390-1019581390-1020031390-1020041390-1020051390-1020061390-1020071390-1020081390-1020091390-1020111390-1020121390-1020131390-1020141390-1020151390-1020161390-1020171390-1020181390-1020191390-1020201390-1021411390-1024601390-1024611390-1024621390-1024631390-1024641390-102465
- SERIAL NUMBERS OF UNITS IN THE US
- Amount recalled
- total 2955 units (2117 units in US and 838 units outside US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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