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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65657

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 10, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rauland-Borg Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

Z-2213-2013
Recall number
Z-2213-2013
Initiated
May 10, 2013
Classification
Class II
Status
Terminated
Recalling firm
Rauland-Borg Corp
Quantity
Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Counterfeit

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

Code information

1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller)

Distribution pattern

Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.

Field note

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