Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Manage

FDA device recall Z-0690-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.

Action taken

SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engineer. Your field service engineer will be contacting you early in 2012 to schedule a mutually agreeable time to upgrade all of your affected modules. Upgrades will be performed on-site and at no cost to you. For any questions about this corrective action program, please call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support or, outside the United States, 1-425-657-7200 x5089.

Root cause

Process change control

Status

Terminated

Product code

DSI

Quantity affected

6722 units worldwide (3598 units in US and 3124 units outside US)

Distribution

Worldwide Distribution -- USA (nationwide)

Date initiated

2011-11-03

Date posted

2012-01-11

Date terminated

2012-09-19

Location

Issaquah, WA

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