Spacelabs Healthcare, Incorporated: The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Recall number

Z-3185-2011

Recalling firm

Spacelabs Healthcare, Incorporated

Product

The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Status

Terminated

Initiated

2010-04-14

Posted

2011-09-12

Terminated

2011-09-12

Reason

There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries.

Root cause

Component design/selection

Action

SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.

Quantity

614 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.

Lot, serial or model codes

SERIAL NUMBERS: 1220M000275, 1220M000538, 1220M000552, 1220M000781, 1220M000902, 1220M000908, 1220M000910, 1220M000915, 1220M000917, 1220M000918, 1220M000919, 1220M000923, 1220M000925, 1220M000927, 1220M000928, 1220M000929, 1220M000930, 1220M000931, 1220M000932, 1220M000934, 1220M000935, 1220M000937, 1220M000938, 1220M000940, 1220M000941, 1220M000943, 1220M000944, 1220M000945, 1220M000947, 1220M000949, 1220M000950, 1220M000952, 1220M000953, 1220M000954, 1220M000955, 1220M000956, 1220M000957, 1220M000958, 1220M000959, 1220M000960, 1220M000962, 1220M000963, 1220M000964, 1220M000966, 1220M000968, 1220M000971, 1220M000972, 1220M000973, 1220M000974, 1220M000975, 1220M000977, 1220M000979, 1220M000980, 1220M000981, 1220M000982, 1220M000984, 1220M000985, 1220M000995, 1220M000996, 1220M000997, 1220M000999, 1220M001000, 1220M001001, 1220M001002, 1220M001003, 1220M001004, 1220M001005, 1220M001006, 1220M001007, 1220M001008, 1220M001009, 1220M001010, 1220M001013, 1220M001014, 1220M001015, 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1220M001742.

510(k) numbers

["K082045"]

PMA numbers

not on file

Product code

MHZ

Firm FEI

3010157426

Firm city

Issaquah

Firm state

WA

Firm country

not on file

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

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