Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Monitor is intended to aler

FDA device recall Z-1705-2012 · posted 2012-06-05 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involuntarily shut down.

Action taken

The firm, Spacelabs Healthcare, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 22, 2012 via return receipt requested, to US customers. On May 29, 2012 a translated customer letter was emailed to all international subsidiaries and distributors of record. The letter describes the product, problem and actions to be taken. The customers were instructed to notify staff of the potential failure and to only tighten the power supply screw with their fingers. In addition, the firm will schedule a time to upgrade the monitors at the customers site. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root cause

Device Design

Status

Terminated

Product code

MHX

Quantity affected

1898 monitors (Domestic: 1188) (International: 710)

Distribution

Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Chile, China, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Malaysia, Netherla

Date initiated

2012-05-22

Date posted

2012-06-05

Date terminated

2013-05-07

Location

Issaquah, WA

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