Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-pa

FDA device recall Z-1542-2015 · posted 2015-04-28 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare Inc

Reason for recall

Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.

Action taken

Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Root cause

Software design

Status

Terminated

Product code

DSI

Quantity affected

1999 units total (1932 in the US and 67 international)

Distribution

Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.

Date initiated

2015-04-17

Date posted

2015-04-28

Date terminated

2015-11-13

Location

Snoqualmie, WA

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