FDA Enforcement Class II Terminated

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: Z-0196-2013 · Reported November 14, 2012

Enforcement

Recall Number: Z-0196-2013
Event ID: 63506
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Spacelabs Healthcare, Llc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: November 14, 2012
Initiation Date: October 5, 2012
Classification Date: November 5, 2012
Termination Date: March 25, 2013
Address: 5150 220th Ave Se, N/A, Issaquah, WA, 98029-6834, United States

Description

Reason

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

Code Info

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.

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

Quantity

169 units distributed (98 in US and 71 Internationally)