Spacelabs Healthcare, Llc: The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.

Recall number

Z-0196-2013

Recalling firm

Spacelabs Healthcare, Llc

Product

The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.

Status

Terminated

Initiated

2012-10-05

Posted

2012-11-05

Terminated

2013-03-25

Reason

Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.

Root cause

Vendor change control

Action

Spacelabs Healthcare sent a URGENT - MEDICAL DEVICE CORRECTION letter dated October 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to advise their staff of this potential failure and advise them to ensure the alarm lights are functional. The firm will contact the consignee at the earliest possible date to schedule a convenient time for the hospital to upgrade the affected product at no cost. Customers can call Technical Support at 1-800-522-7025 and select 2 for any questions about this recall.

Quantity

169 units distributed (98 in US and 71 Internationally)

Distribution

Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom

Lot, serial or model codes

Serial Number for U.S. Cosignees: PRO-12240004, PRO-12240015, PRO-12240017, PRO-12240018, PRO-12240022, PRO-12240026, PRO-12240028, PRO-12240030, PRO-12240031, PRO-12240032, PRO-12240033, PRO-12240034, PRO-12240036, PRO-12240037, PRO-12240038, PRO-12240040, PRO-12240041, PRO-12240058, PRO-12240059, PRO-12240062, PRO-12240063, PRO-12240077, PRO-12240084, PRO-12240090, pro-12260008, PRO-12260016, pro-12260018, PRO-12260023, pro-12260024, PRO-12260032, pro-12260033, pro-12260035, PRO-12260036, PRO-12260037, pro-12260038, pro-12260041, pro-12260044, pro-12260055, pro-12260059, PRO-12260060, PRO-12260062, pro-12260064, pro-12260065, pro-12260068, pro-12260070, pro-12260071, pro-12260073, PRO-12260076, PRO-12260077, PRO-12260080, PRO-12260081, PRO-12260082, PRO-12260083, PRO-12260085, PRO-12260086, PRO-12260087, PRO-12260088, PRO-12260092, PRO-12260094, PRO-12260096, PRO-12260097, pro-12260121, pro-12260125, pro-12260131, pro-12260164, pro-12260167, pro-12260172, PRO-12260175, PRO-12260183, pro-12260185, pro-12280036, pro-12280049, pro-12280062, pro-12280119, pro-12280121, pro-12280126, pro-12280127, pro-12280131, pro-12280133, pro-12280134, pro-12280136, pro-12280137, pro-12280152, pro-12280155, pro-12280156, pro-12280160, pro-12280161, pro-12280162, pro-12280163, pro-12280173, pro-12280174, pro-12280175, pro-12280177, pro-12280182, pro-12280205, pro-12280232, pro-12280272, pro-12280273.   Serial number for International Consignees:  PRO-12240056, PRO-12260005, pro-12260006, PRO-12260012, PRO-12260013, pro-12260019, PRO-12260020, PRO-12260021, pro-12260022, pro-12260025, pro-12260026, pro-12260027, pro-12260028, PRO-12260029, PRO-12260030, pro-12260031, PRO-12260040, PRO-12260043, PRO-12260045, PRO-12260046, pro-12260047, PRO-12260051, PRO-12260053, PRO-12260057, PRO-12260075, pro-12260079, PRO-12260111, PRO-12260118, PRO-12260122, pro-12260124, pro-12260128, pro-12260140, pro-12260143, PRO-12260146, PRO-12260147, PRO-12260149, PRO-12260151, PRO-12260152, PRO-12260153, PRO-12260155, PRO-12260156, PRO-12260157, pro-12260158, PRO-12260159, PRO-12260160, PRO-12260161, PRO-12260162, PRO-12260163, PRO-12260169, PRO-12260170, pro-12260171, pro-12260174, PRO-12260176, PRO-12260178, pro-12260179, pro-12260180, pro-12260182, pro-12260189, pro-12260190, pro-12260191, PRO-12260192, pro-12260193, pro-12260195, pro-12260199, pro-12280006, pro-12280023, pro-12280132, pro-12280135, pro-12280141, pro-12280206, pro-12280225.

510(k) numbers

["K112962"]

PMA numbers

not on file

Product code

MHX

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

Copy